XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM Adverse Event — Malfunction (MDR 2024168-2020-03977)
XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM Adverse Event — Malfunction (MDR 2024168-2020-03977) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; Generic name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM; Manufact
| Device | XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM |
|---|---|
| Generic name | DRUG ELUTING CORONARY STENT DELIVERY SYSTEM |
| Manufacturer | ABBOTT VASCULAR |
| Report number | 2024168-2020-03977 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT |
| Source | openFDA MAUDE (device adverse events) |
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