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 CDS07 CDS0701-XTW manufactured by Abbott Vascular.
[187713893]
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 did not indicate a lot-specific product issue. All information was investigated and a cause for the reported slda in this complaint could not be determined. The reported patient effect of persistent or residual mitral regurgitation as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures. The reported mr was likely due to the slda. There is no indication of a product issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
[187713894]
This is being filed to report that the clip detached from one leaflet and the mr increased. It was reported that the initial mitraclip procedure was performed on (b)(6) 2020, to treat mixed mitral regurgitation (mr) with a grade of 4. One clip was implanted, reducing mr to 1-2. On (b)(6) 2020, the patient returned for a follow up where it was noted the clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment (slda)). The mr increased to 4. No treatment is planned at this time and the patient will be medically managed. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03116 |
| MDR Report Key | 9901309 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-10-23 |
| 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 | CDS07 |
| Generic Name | VALVE REPAIR |
| Product Code | NKM |
| Date Received | 2020-03-30 |
| Model Number | CDS0701-XTW |
| Catalog Number | CDS0701-XTW |
| Lot Number | 91019U192 |
| 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 |