Devices › Absorbable coronary drug-eluting stent
Device brand name · Bioresorbable drug eluting scaffold
Absorb Bioresorbable Vascular Scaffold System: medical device reports filed with FDA
1,085 reports name it, 2012–2026. Manufacturer given most often on reports: Av-Temecula-Ct. Product code PNY.
- 1,085
- device reports naming the brand
- 0% of all MAUDE reports · about 78 a year
- 11
- reports, 12 months to August 2026
- 11 in the 12 months before
- 35.7%
- classified as malfunction
- 3.8% across the product code
- 8.3%
- classified as death, as reported
- 90 reports · not verified by FDA
FDA's MAUDE database holds 1,085 reports that name the brand "Absorb Bioresorbable Vascular Scaffold System" (bioresorbable drug eluting scaffold), received between September 2012 and February 2026; the manufacturer given most often on reports is Av-Temecula-Ct. Spellings of one product vary from report to report.
11 reports arrived in the 12 months to August 2026, close to the 11 of 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 injury (56%), malfunction (35.7%) and death (8.3%); across all absorbable coronary drug-eluting stent reports (product code PNY) death is recorded in 11.8% and malfunction in 3.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are difficult to remove (13.8%), detachment of device component (11.2%) and inflation problem (9.2%). The patient problems coded most often are thrombosis, stenosis and angina. 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 929 reports carrying product code PNY. 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 |
|---|---|---|---|
| Difficult to removethe device was hard to remove | 150 | 13.8% | 0.4% |
| Detachment of device component | 122 | 11.2% | 1% |
| Inflation problem | 100 | 9.2% | 0.3% |
| Improper or incorrect procedure or method | 75 | 6.9% | 4.5% |
| Failure to advance | 70 | 6.5% | 0.6% |
| Material rupture | 68 | 6.3% | 0.6% |
| Breakthe device broke | 49 | 4.5% | 1.1% |
| Difficult or delayed positioning | 33 | 3% | 2.8% |
| Leak/splashthe device leaked | 32 | 2.9% | 0% |
| Positioning failure | 22 | 2% | 0.5% |
| Difficult to position | 21 | 1.9% | 0.6% |
| Kinkedthe tube or line kinked | 20 | 1.8% | 0.1% |
| Patient-device incompatibilitythe device did not suit the patient | 20 | 1.8% | 2.9% |
| Torn material | 17 | 1.6% | 0% |
| Device dislodged or dislocated | 14 | 1.3% | 0.1% |
| Material deformation | 14 | 1.3% | 0.4% |
| Peeled/delaminated | 11 | 1% | 0% |
| Physical resistance | 11 | 1% | 0.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 7 | 0.6% | 0.6% |
| Deflation problem | 6 | 0.6% | 0% |
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 |
|---|---|---|
| Thrombosis | 285 | 26.3% |
| Stenosis | 235 | 21.7% |
| Angina | 230 | 21.2% |
| Myocardial infarctionheart attack | 226 | 20.8% |
| No patient involvement | 109 | 10% |
| Deaththe patient died; cause not stated by this term | 82 | 7.6% |
| Intimal dissection | 38 | 3.5% |
| Aneurysm | 36 | 3.3% |
| Dyspneashortness of breath | 24 | 2.2% |
| Ischemia | 22 | 2% |
| Occlusion | 19 | 1.8% |
| Perforation | 16 | 1.5% |
| Cardiac arrestthe heart stopped | 15 | 1.4% |
| Cardiac enzyme elevation | 14 | 1.3% |
| Non specific ekg/ECG changes | 14 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Absorb Bioresorbable Vascular Scaffold System | Product code PNY | All MAUDE reports |
|---|---|---|---|
| Reports | 1,085 | 929 | 26,136,888 |
| Share of that pool | — | 116.8% | 0% |
| Classified as death, per 1,000 reports | 83 | 118 | 9 |
| Classified as injury | 56% | 84.4% | 36.2% |
| Classified as malfunction | 35.7% | 3.8% | 62.3% |
| Filed by the manufacturer | 100% | 99.6% | 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 PNY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Absorb Gt1 Bioresorbable Vascular Scaffold System | 200 | 0 | 9% |
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 Absorb Bioresorbable Vascular Scaffold System reports
How many FDA reports name Absorb Bioresorbable Vascular Scaffold System?
1,085 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 11 in the latest 12 months.
What kinds of events are reported?
injury (56%), malfunction (35.7%) and death (8.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
difficult to remove (13.8%), detachment of device component (11.2%), inflation problem (9.2%), improper or incorrect procedure or method (6.9%) and failure to advance (6.5%). 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 Absorb Bioresorbable Vascular Scaffold System 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.