MITRACLIP CLIP DELIVERY SYSTEM Adverse Event — Malfunction (MDR 2024168-2020-03975)
MITRACLIP CLIP DELIVERY SYSTEM Adverse Event — Malfunction (MDR 2024168-2020-03975) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MITRACLIP CLIP DELIVERY SYSTEM; Generic name: VALVE REPAIR; Manufacturer: ABBOTT VASCULAR.
| Device | MITRACLIP CLIP DELIVERY SYSTEM |
|---|---|
| Generic name | VALVE REPAIR |
| Manufacturer | ABBOTT VASCULAR |
| Report number | 2024168-2020-03975 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THIS REPORT IS RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. ARTICLE ATTACHED: IMPACT OF LEFT ATRIAL DIAMETER ON OUTCOME IN PATIENTS UNDERGOING EDGE-TO-EDGE MITRAL VALVE REPAIR: RESULTS FROM THE GERMAN TRANSCATHETER MITRAL VALVE INTERVENTIONS (TRAMI) REGISTRYNA - ATTACHMENT: [ARTICLE CN-030243.PDF]. |
| Source | openFDA MAUDE (device adverse events) |
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