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 2020-03-05 for MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM CDS0502 manufactured by Abbott Vascular.
[182289034]
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no similar complaints reported from this lot. The investigation determined the reported device causing damage to another device appears to be related to user technique which resulted in the inability to grasp (positioning failure). There is no indication of a product issue with respect to manufacture, design or labeling. The additional clip delivery system (cds0502) device referenced is filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10
[182289035]
This is filed to report the device causing damage to another device. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. One clip delivery system (cds) (90824u149) was advanced and the clip was successfully implanted at a1/p1. A second cds was inserted and was attempted to implanted; however, the clip came in contact with the implanted, causing damage the implanted clip to partially detach from the anterior leaflet. It was noted that no tissue damage occurred. The second clip was then attempted to be implanted to stabilize the first clip, but due to the movement of the first clip during cardiac beats the leaflets could not be grasped. Therefore, for safety reason, the physician decided not to implant the second clip. The clip was retracted, and the procedure was aborted. Mr remained at a grade of 4. There was no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02041 |
| MDR Report Key | 9793698 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2019-10-07 |
| Date Added to Maude | 2020-03-05 |
| 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 | 2020-03-05 |
| Catalog Number | CDS0502 |
| Lot Number | 91007U132 |
| 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 | 2020-03-05 |