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-NTR manufactured by Abbott Vascular.
[187720469]
The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event. The reported patient effect of mitral valve injury (tissue damage), as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures. Based on the information reviewed, the tissue damage was reported to be due to the fragile leaflets and therefore related to patient morphology/pathology. There is no indication of a product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
[187720470]
This is filed to report tissue damage. It was reported that this was a mitraclip procedure performed to treat functional mitral regurgitation (mr), with an mr grade of 4. Echo imaging was challenging. Two clips were implanted reducing mr to 2. To further reduce mr, a third clip (9113u259) was advanced to the mitral valve and the leaflets were grasped. When preparing to remove the lock line, it was noticed that mr increased to 2-3. The lock lever cap was placed back on, securing the lock line in place, unlocking, and removing the clip. A leaflet tear was suspected, due to the fragile leaflets. Another clip, was advanced, but leaflet capture was not successful due to short posterior leaflet and deteriorating echo image. The clip was not implanted and was removed. A total of two clips were implanted, reducing mr to 3. The patient was converted to open heart surgery for mitral replacement. The patient remained stable. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03166 |
| MDR Report Key | 9908012 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-11-14 |
| 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-NTR |
| Lot Number | 91113U259 |
| 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. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2020-03-31 |