XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM Adverse Event — Injury (MDR 2024168-2020-03921)
XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM Adverse Event — Injury (MDR 2024168-2020-03921) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; Generic name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM; M
| Device | XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM |
|---|---|
| Generic name | DRUG ELUTING CORONARY STENT DELIVERY SYSTEM |
| Manufacturer | ABBOTT VASCULAR |
| Report number | 2024168-2020-03921 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THE STENT REMAINS IN THE PATIENT. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECT OF INTIMAL DISSECTION IS LISTED IN THE XIENCE XPEDITION, EVEROLIMUS ELUTING CORONARY STENT SYSTEM, INSTRUCTIONS FOR USE (IFU) AS A KNOWN PATIEN |
| Source | openFDA MAUDE (device adverse events) |
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