PROMUS PREMIER SELECT Adverse Event — Malfunction (MDR 2134265-2020-04914)
PROMUS PREMIER SELECT Adverse Event — Malfunction (MDR 2134265-2020-04914) 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 | 2134265-2020-04914 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: P SELECT OUS MR 16 X 4.00MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND SIGNS OF STENT DAMAGE. STENT STRUTS ON PROXIMAL REGION OF THE STENT WERE NOTED TO BE LIFTED AND PULLED IN A DISTAL DIRECTION. THE UNDAMAGED STENT OD (OUTER DIAMETER) WAS MEASURED AND |
| Source | openFDA MAUDE (device adverse events) |
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