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 2020-03-30 for MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM CDS0601-XTR manufactured by Abbott Vascular.
[187715990]
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. The reported patient effects of thrombosis, as listed in the instructions for use, is a known possible complication associated with mitraclip procedures. Based on the information reviewed, the investigation was unable to determine a conclusive cause for the thrombosis. There is no indication of a product issue with respect to manufacture, design, or labeling.
Patient Sequence No: 1, Text Type: N, H10
[187715991]
This is filed to report thrombus. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+. One clip was successfully implanted at a2p2, reducing mr to a grade of 3. To further reduce mr, an additional clip (90918u195) was inserted. However, when the clip exited the end of the steerable guide catheter (sgc), an object appeared to be attached to the clip delivery system (cds), which the physician suspected to be thrombus. The activated clotting time (act) was checked and was noted to be 384. It was also noted that the act was above 400 throughout most of the procedure. The cds was removed without issues, and was inspected on the back table, but the physician was unable to find any evidence of thrombus or tissue attached to the cds. An additional clip was inserted and placed laterally of the implanted clip, reducing mr to a grade of 1-2. There was no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03117 |
| MDR Report Key | 9901338 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-09-19 |
| 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 |
| Model Number | CDS0601-XTR |
| Catalog Number | CDS0601-XTR |
| Lot Number | 90918U195 |
| 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 |