MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM CDS0602-XTR manufactured by Abbott Vascular.
[186376878]
Date of event - estimated, implant date - estimated, explant date - estimated. The device was discarded. Investigation is not yet complete. A follow-up will be submitted with all relevant information. Attached article,:? Transcatheter edge-to-edge tricuspid repair for recurrence of valvular regurgitation after left ventricular assist device and tricuspid ring implantation.?
Patient Sequence No: 1, Text Type: N, H10
[186376879]
This is filed to report the single leaflet device attachment/slda. It was reported through a research article; the mitraclip procedure was performed in a patient with a left ventricular assist device, and a previous rigid ring in the tricuspid valve as adjunctive bridge to heart transplantation. Two clips were implanted in the tricuspid valve, reducing tr. Approximately one month post clip implantation, the patient went in for a heart transplant and it was noted that one clip detached from the septal leaflet, and remained attached to the anterior leaflet (slda). Details are listed in the attached article, titled? Transcatheter edge-to-edge tricuspid repair for recurrence of valvular regurgitation after left ventricular assist device and tricuspid ring implantation.? Please see article for additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03188 |
| MDR Report Key | 9908721 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-06-01 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LINDSEY BELL |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, REG # 3005070406 |
| Manufacturer Street | 3885 BOHANNON DRIVE |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM |
| Generic Name | VALVE REPAIR |
| Product Code | NKM |
| Date Received | 2020-03-31 |
| Catalog Number | CDS0602-XTR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |