PROTEGE RX CAROTID STENT SYSTEM Adverse Event — Malfunction (MDR 2183870-2020-00130)
PROTEGE RX CAROTID STENT SYSTEM Adverse Event — Malfunction (MDR 2183870-2020-00130) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PROTEGE RX CAROTID STENT SYSTEM; Generic name: STENT, CAROTID; Manufacturer: COVIDIEN.
| Device | PROTEGE RX CAROTID STENT SYSTEM |
|---|---|
| Generic name | STENT, CAROTID |
| Manufacturer | COVIDIEN |
| Report number | 2183870-2020-00130 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | PRODUCT ANALYSIS: THE PROTÉGÉ RX WAS RETURNED WAS RETURNED TO MEDTRONIC INVESTIGATION LAB FOR EVALUATION. NO ANCILLARY DEVICES WERE INCLUDED. A VISUAL INSPECTION INDICATED THE STENT WAS NOT DEPLOYED. THE HYPOTUBE WAS NOT ADVANCED AND THE STENT WAS OBSERVED LOADED ON THE CATHETER. THE STRAIN RELIEF INDICATED 9 X 40 MM, WHICH IN CONSISTENT WITH THE PRODUCT LABELING. IT WAS OBSERVED THE DISTAL TIP AS |
| Source | openFDA MAUDE (device adverse events) |
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