CYPHER SIROLIMUS-ELUTING CORONARY STENT Adverse Event — Malfunction (MDR 9616099-2008-00358)
CYPHER SIROLIMUS-ELUTING CORONARY STENT Adverse Event — Malfunction (MDR 9616099-2008-00358) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CYPHER SIROLIMUS-ELUTING CORONARY STENT; Generic name: DRUG-ELUTING STENT (NIQ); Manufacturer: CORDIS DE MEXICO.
| Device | CYPHER SIROLIMUS-ELUTING CORONARY STENT |
|---|---|
| Generic name | DRUG-ELUTING STENT (NIQ) |
| Manufacturer | CORDIS DE MEXICO |
| Report number | 9616099-2008-00358 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Foreign, Health Professional, Company representation |
| Narrative | THE PT HAD A DE NOVO LESION IN THE DISTAL CIRCUMFLEX. THE LESION WAS SLIGHTLY TORTUOUS AND MODERATELY CALCIFIED WITH 90% STENOSIS. THE LESION WAS PRE-DILATED. WHILE 3.5X13MM CYPHER WAS BEING DELIVER TO THE LESION THE PHYSICIAN FELT FRICTION IN THE PROXIMAL CIRCUMFLEX AND REMOVED THE STENT DELIVERY SYSTEM FROM THE PT. THE PHYSICIAN CONFIRMED THAT THE DISTAL END OF THE STENT WAS FLARED. THEREFORE, H |
| Source | openFDA MAUDE (device adverse events) |
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