PROMUS PREMIER Adverse Event — Malfunction (MDR 2134265-2020-05756)
PROMUS PREMIER Adverse Event — Malfunction (MDR 2134265-2020-05756) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PROMUS PREMIER; Generic name: STENT, CORONARY, DRUG-ELUTING; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | PROMUS PREMIER |
|---|---|
| Generic name | STENT, CORONARY, DRUG-ELUTING |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-05756 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED, 3.8MM DIFFUSE TARGET LESION WAS LOCATED IN THE MID AND DISTAL END OF THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED OSTIAL RIGHT CORONARY ARTERY. A 38 X 4.00 PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS. AFTER DEVICE WITHDRAWAL, IT WAS NOTED THAT THE STENT WAS DEFORMED AND THE STENT STRUTS WERE LIFTED. THE PROCEDURE |
| Source | openFDA MAUDE (device adverse events) |
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