PROMUS PREMIER SELECT Adverse Event — Malfunction (MDR 2134265-2020-04974)
PROMUS PREMIER SELECT Adverse Event — Malfunction (MDR 2134265-2020-04974) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PROMUS PREMIER SELECT; Generic name: STENT, CORONARY, DRUG-ELUTING; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | PROMUS PREMIER SELECT |
|---|---|
| Generic name | STENT, CORONARY, DRUG-ELUTING |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-04974 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: A 28 X 2.50MM PROMUS PREMIER SELECT STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. AN EXAMINATION (VISUAL AND VIA SCOPE) OF THE STENT FOUND STENT DAMAGE. PROXIMAL STENT STRUTS WERE LIFTED FROM THEIR CRIMPED POSITION. THE UNDAMAGED STENT OUTER DIAMETER WAS MEASURED BY SNAP GAUGE AND THE RESULT WAS |
| Source | openFDA MAUDE (device adverse events) |
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