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 2020-03-26 for MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM CDS0602-NTR manufactured by Abbott Vascular.
[188398106]
Date of event: estimated. 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. Additionally, a review of the complaint history identified no similar complaints reported from this lot. The reported patient effect of recurrent mitral regurgitation (mr), as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures. Based on the information provided a conclusive cause for the reported post procedure single leaflet device attachment (slda) cannot be determined. The reported recurrent mr is the result of 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
[188398107]
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 mixed mitral regurgitation (mr). Imaging was challenging due to the rotated heart. Two clips were implanted, reducing mr from 4+ to 2. On an unspecified date, during a follow up visit echocardiogram was performed. It was noted clip (91009u119) detached from the posterior leaflet and remained attached to the anterior leaflet, (slda) and mr increased to 3. No symptoms were reported and the patient remains stable. The patient is being assessed for possible future treatment. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02984 |
| MDR Report Key | 9885489 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-01 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-10-09 |
| 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 |
| Catalog Number | CDS0602-NTR |
| Lot Number | 91009U119 |
| 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 | 2020-03-26 |