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 CDS0601-XTR manufactured by Abbott Vascular.
[185093114]
The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history identified no lot specific product issue. All available information was investigated and a definitive cause for the reported slda could not be determined in this complaint; however, the recurrent mr was due to slda. The reported patient effect of mitral regurgitation as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures. There is no indication of product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
[185093115]
This is being filed to report that the clip detached from one leaflet. It was reported that the mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with grade 4. The clip delivery system (cds) was advanced to the mitral valve and the clip was deployed successfully, reducing mr to 2. However, when the cds was removed, it was noted that the clip detached from the posterior leaflet and remained attached to the anterior leaflet, single leaflet device attachment (slda) and mr increased to 4. The patient is stable. In two weeks, the patient will be evaluated for surgical repair. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02952 |
| MDR Report Key | 9884267 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-09-19 |
| 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 | CDS0601-XTR |
| Catalog Number | CDS0601-XTR |
| Lot Number | 90918U121 |
| 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 | 2020-03-26 |