Devices › Iliac covered stent, arterial
Device brand name · Balloon expandable vascular covered stent
Lifestream: medical device reports filed with FDA
1,012 reports name it, 2017–2026. Manufacturer given most often on reports: Clearstream Technologies. Product code PRL.
- 1,012
- device reports naming the brand
- 0% of all MAUDE reports · about 110 a year
- 227
- reports, 12 months to August 2026
- 168 in the 12 months before
- 88.1%
- classified as malfunction
- 57.9% across the product code
- 0.5%
- classified as death, as reported
- 5 reports · not verified by FDA
FDA's MAUDE database holds 1,012 reports that name the brand "Lifestream" (balloon expandable vascular covered stent), received between May 2017 and August 2026; the manufacturer given most often on reports is Clearstream Technologies. Spellings of one product vary from report to report.
227 reports arrived in the 12 months to August 2026, up 35% from 168 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (88.1%), injury (11.3%) and death (0.5%); across all iliac covered stent, arterial reports (product code PRL) death is recorded in 2.8% and malfunction in 57.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device dislodged or dislocated (80.7%), device-device incompatibility (12.5%) and material deformation (10.7%). The patient problems coded most often are appropriate clinical signs, symptoms and conditions term/code not available, foreign body in patient and no patient involvement. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,647 reports carrying product code PRL. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Device dislodged or dislocated | 817 | 80.7% | 42.7% |
| Device-device incompatibility | 127 | 12.5% | 7.3% |
| Material deformation | 108 | 10.7% | 6.2% |
| Failure to advance | 64 | 6.3% | 3.4% |
| Retraction problem | 46 | 4.5% | 2% |
| Difficult to open or remove packaging material | 22 | 2.2% | 0.8% |
| Difficult to advance | 20 | 2% | 1.7% |
| Migration or expulsion of device | 20 | 2% | 1.2% |
| Material rupture | 14 | 1.4% | 1.2% |
| Material split, cut or torn | 13 | 1.3% | 0.8% |
| Activation, positioning or separation problem | 11 | 1.1% | 1.5% |
| Physical resistance | 11 | 1.1% | 0.4% |
| Separation failure | 11 | 1.1% | 0.6% |
| Breakthe device broke | 10 | 1% | 1.5% |
| Difficult to insertthe device was hard to insert | 9 | 0.9% | 0.8% |
| Packaging problem | 9 | 0.9% | 0.3% |
| Detachment of device or device componentpart of the device came off | 8 | 0.8% | 4.3% |
| Occlusion within devicethe device blocked | 8 | 0.8% | 0.5% |
| Inflation problem | 7 | 0.7% | 0.6% |
| Deflation problem | 5 | 0.5% | 0.5% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Appropriate clinical signs, symptoms and conditions term/code not available | 36 | 3.6% |
| Foreign body in patientpart of a device left in the patient | 19 | 1.9% |
| No patient involvement | 17 | 1.7% |
| Stenosis | 14 | 1.4% |
| Hemorrhage/blood loss/bleeding | 8 | 0.8% |
| Claudication | 4 | 0.4% |
| Obstruction/occlusion | 4 | 0.4% |
| Abdominal painstomach or belly pain | 2 | 0.2% |
| Blood loss | 2 | 0.2% |
| Calcium deposits/calcification | 2 | 0.2% |
| Hematomaa collection of blood under the skin or in tissue | 2 | 0.2% |
| Injurya physical injury | 2 | 0.2% |
| Ischemia | 2 | 0.2% |
| Low blood pressure/ hypotension | 2 | 0.2% |
| Painpain, site not specified | 2 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Lifestream | Product code PRL | All MAUDE reports |
|---|---|---|---|
| Reports | 1,012 | 2,647 | 26,136,888 |
| Share of that pool | — | 38.2% | 0% |
| Classified as death, per 1,000 reports | 5 | 28 | 9 |
| Classified as injury | 11.3% | 39.3% | 36.2% |
| Classified as malfunction | 88.1% | 57.9% | 62.3% |
| Filed by the manufacturer | 99.6% | 98.7% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code PRL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis | 1,485 | 295 | 4.9% |
| Lifestream Balloon Expandable Vascular Covered Stent | 181 | 0 | 4.4% |
| GORE VIABAHN Endoprosthesis with HEPARIN Bioactive Surface | 906 | 174 | 2.1% |
| GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface | 341 | 91 | 0.6% |
| Bard | 1,124 | 2 | 1.8% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Lifestream reports
How many FDA reports name Lifestream?
1,012 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 227 in the latest 12 months.
What kinds of events are reported?
malfunction (88.1%), injury (11.3%) and death (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device dislodged or dislocated (80.7%), device-device incompatibility (12.5%), material deformation (10.7%), failure to advance (6.3%) and retraction problem (4.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Lifestream was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.