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 2020-03-30 for MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM CDS0602-NTR manufactured by Abbott Vascular.
[188561716]
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that could have contributed to the reported issues. Additionally, a review of the complaint history did not identify a lot specific issue for the reported lot. The reported patient effect of chordal rupture (tissue damage) as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures. Based on the available information, the reported difficult to remove (anatomy) was due to procedural conditions as the clip got caught in the chordae. The reported tissue damage was an effect of the reported difficult to remove from anatomy as a chordal rupture was noted during attempts to free the clip from the chordae. The reported unintended movement was due to procedural conditions as it was noted that the transeptal puncture was not optimal (it was too high) and the clip slipped into the medial segment when advanced to the valve. There is no indication of product quality issue with respect to manufacture, design or labeling. The other mitraclip is filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10
[188561717]
This is filed to report tissue damage. It was reported that this was a mitraclip procedure performed to treat degenerative mitral regurgitation (mr), it was reported that this was a mitraclip procedure performed to treat degenerative mitral regurgitation (mr), with an mr grade of 3. The transseptal puncture was high, 5. 5cm. The clip delivery system (cds) (91019u222) was advanced to the mitral valve. After grasping the leaflets, the clip failed the final arm angle test twice. The clip was not implanted and was removed. Another clip (91106u183) was advanced, but the clip slipped too medial and got caught in chordae. Troubleshooting was performed and the clip was freed; however, a chordae rupture occurred. The clip was implanted, and mr reduced. To further reduce mr another clip was implanted, reducing mr to 1. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03114 |
| MDR Report Key | 9901292 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-11-07 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| Catalog Number | CDS0602-NTR |
| Lot Number | 91106U183 |
| 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 | 2020-03-30 |