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.
[187714108]
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 this event. Additionally, a review of the complaint history did not identify a lot specific issue. The reported patient effects of worsening mitral regurgitation (mr) and dyspnea, as listed in the mitraclip ntr/xtr instructions for use, are known possible complications associated with mitraclip procedures. Based on the information available, the reported single leaflet device attachment (slda) was due to challenging anatomy. The reported recurrent mr was a cascading effect of the reported slda. The reported dyspnea was a cascading effect of the reported recurrent mr. There is no indication of product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
[187714109]
This is filed to report the single leaflet device attachment (slda). It was reported that the initial mitraclip procedure was performed on (b)(6) 2020 to treat degenerative mitral regurgitation (mr). One clip was implanted, reducing mr from 4+ to 2. On (b)(6) 2020, the patient presented experiencing dyspnea. Echocardiogram was performed and it was noted that the clip detached from the posterior leaflet and remained attached to the anterior leaflet, (slda). Mr increased to 4+. A second mitraclip procedure has not been scheduled. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03119 |
| MDR Report Key | 9901352 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-06-10 |
| 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 | 90608U171 |
| 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 |