MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-26 for MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM CDS0701-NTW manufactured by Abbott Vascular.
[188207906]
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot. The reported patient effect of tissue damage as listed in the instructions for use (eifu), mitraclip system gen 4, u. S. , is a known possible complication associated with mitraclip procedures. The investigation was unable to determine a conclusive cause for the tissue damage. There is no indication of a product issue with respect to manufacture, design, or labeling.
Patient Sequence No: 1, Text Type: N, H10
[188207907]
This is filed for chordal damage. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+. Patient anatomy included a prolapse/flail. The ntw clip was able to grasp the leaflets; however, after the leaftlet grasp, the mr increased slightly and it was noted that there was possibly chordal damage. It was noted that a chord seemed to be more visible than before leaflet grasping. The device was removed without difficulty. An xtw clip was then used and was deployed without issue. No treatment was provided to treat the possible tissue damage. The mr was reduced from grade 4+ to grade 2+. There were no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02988 |
| MDR Report Key | 9885595 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-10-30 |
| Date Added to Maude | 2020-03-26 |
| 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 | 2020-03-26 |
| Model Number | CDS0701-NTW |
| Catalog Number | CDS0701-NTW |
| Lot Number | 91028U127 |
| 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 | 1. Other | 2020-03-26 |