SMART CONTROL NITINOL STENT SYSTEM Adverse Event — Injury (MDR 9616099-2008-00347)
SMART CONTROL NITINOL STENT SYSTEM Adverse Event — Injury (MDR 9616099-2008-00347) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SMART CONTROL NITINOL STENT SYSTEM; Generic name: SELF EXPANDING STENTS (NIO); Manufacturer: CORDIS DE MEXICO.
| Device | SMART CONTROL NITINOL STENT SYSTEM |
|---|---|
| Generic name | SELF EXPANDING STENTS (NIO) |
| Manufacturer | CORDIS DE MEXICO |
| Report number | 9616099-2008-00347 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2008-02-14 |
| Report source | Health Professional, Company representation |
| Narrative | WHILE THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE SMART CONTROL (C06100ML) INTO THE PT'S SUPERFICIAL FEMORAL ARTERY, THE STENT DID NOT FULLY DEPLOY. THE PHYSICIAN HAD TO BREAK THE SMART CONTROL HANDLE AND PULL THE SHEATH BACK IN ORDER TO DEPLOY THE STENT. THE STENT WAS DEPLOYED APPROPRIATELY PER FLUOROSCOPY REPORT. THE PT WAS ASYMPTOMATIC UPON THE PARTIAL DEPLOYMENT AND WAS IN NO DISTRESS. THERE WE |
| Source | openFDA MAUDE (device adverse events) |
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