Devices › Iliac covered stent, arterial
Device brand name · Balloon expandable vascular covered stent
Lifestream Balloon Expandable Vascular Covered Stent: medical device reports filed with FDA
181 reports name it, 2017–2020. Manufacturer given most often on reports: Clearstream Technologies. Product code PRL.
- 181
- device reports naming the brand
- 0% of all MAUDE reports · about 20 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 84.5%
- classified as malfunction
- 57.9% across the product code
- 4.4%
- classified as death, as reported
- 8 reports · not verified by FDA
181 medical device reports received by FDA name the brand "Lifestream Balloon Expandable Vascular Covered Stent" (balloon expandable vascular covered stent); the manufacturer given most often on reports is Clearstream Technologies; received from August 2017 to April 2020. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (84.5%), injury (11%) and death (4.4%); 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 (62.4%), device-device incompatibility (29.8%) and failure to advance (4.4%). The patient problems coded most often are no patient involvement, death and injury. 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
No report naming Lifestream Balloon Expandable Vascular Covered Stent was received in the five years to August 2026; the latest was received in April 2020.
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 | 113 | 62.4% | 42.7% |
| Device-device incompatibility | 54 | 29.8% | 7.3% |
| Failure to advance | 8 | 4.4% | 3.4% |
| Material split, cut or torn | 7 | 3.9% | 0.8% |
| Occlusion within devicethe device blocked | 7 | 3.9% | 0.5% |
| Migration or expulsion of device | 6 | 3.3% | 1.2% |
| Obstruction of flow | 5 | 2.8% | 3.9% |
| Activation, positioning or separation problem | 3 | 1.7% | 1.5% |
| Breakthe device broke | 3 | 1.7% | 1.5% |
| Retraction problem | 3 | 1.7% | 2% |
| Inflation problem | 2 | 1.1% | 0.6% |
| Material deformation | 2 | 1.1% | 6.2% |
| Material rupture | 2 | 1.1% | 1.2% |
| Deflation problem | 1 | 0.6% | 0.5% |
| Delivery system failure | 1 | 0.6% | 0% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.6% | 0.1% |
| Device markings/labelling problema problem with the device markings or label | 1 | 0.6% | 0.2% |
| Difficult to removethe device was hard to remove | 1 | 0.6% | 1% |
| Packaging problem | 1 | 0.6% | 0.3% |
| Partial blockage | 1 | 0.6% | 1.7% |
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 |
|---|---|---|
| No patient involvement | 33 | 18.2% |
| Deaththe patient died; cause not stated by this term | 6 | 3.3% |
| Injurya physical injury | 6 | 3.3% |
| Stenosis | 4 | 2.2% |
| Vascular dissection | 2 | 1.1% |
| Aneurysm | 1 | 0.6% |
| Device embedded in tissue or plaque | 1 | 0.6% |
| Obstruction/occlusion | 1 | 0.6% |
| Occlusion | 1 | 0.6% |
| Painpain, site not specified | 1 | 0.6% |
| Perforation of vessels | 1 | 0.6% |
| Rashskin rash | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Lifestream Balloon Expandable Vascular Covered Stent | Product code PRL | All MAUDE reports |
|---|---|---|---|
| Reports | 181 | 2,647 | 26,136,888 |
| Share of that pool | — | 6.8% | 0% |
| Classified as death, per 1,000 reports | 44 | 28 | 9 |
| Classified as injury | 11% | 39.3% | 36.2% |
| Classified as malfunction | 84.5% | 57.9% | 62.3% |
| Filed by the manufacturer | 100% | 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 | 1,012 | 227 | 0.5% |
| 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 Balloon Expandable Vascular Covered Stent reports
How many FDA reports name Lifestream Balloon Expandable Vascular Covered Stent?
181 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (84.5%), injury (11%) and death (4.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device dislodged or dislocated (62.4%), device-device incompatibility (29.8%), failure to advance (4.4%), material split, cut or torn (3.9%) and occlusion within device (3.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Lifestream Balloon Expandable Vascular Covered Stent 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.