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-NTR manufactured by Abbott Vascular.
[188397132]
The customer reported the device was explanted and will not be returning. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[188397133]
This is being filed for tissue damage, medical intervention, surgical intervention, and prolonged hospitalization. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. It was noted in the medial location there was a possible cleft or restricted posterior leaflet. On (b)(6) 2020, the first clip delivery system (cds) was advanced to the mitral valve, and the clip was deployed. Then a second cds (90508u174) was advanced to the mitral valve, and the clip was placed medial to the first clip; however, it was observed that the first clip became detached form the anterior leaflet but remained attached to the posterior leaflet (single leaflet device attachment/slda). A third clip was deployed lateral to the first clip to stabilize the slda. Three clips were implanted, reducing mr to 3+. On (b)(6) 2020, a decision was made to send the patient to surgery for mitral valve replacement. Surgery was performed due to the slda and to further reduce mr. It was noted that images were evaluated, and it was observed that the second clip (90417u126) had tore the anterior leaflet which was treated during the mitral valve replacement. All the clips were stable at the time of the surgery. On (b)(6) 2020, the patient died. The physician stated that the patient was extremely ill prior to the mitraclip procedure, and that the outcome would have not changed if surgery was performed or not, but this could not be confirmed. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02973 |
| MDR Report Key | 9885065 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-04-18 |
| 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-NTR |
| Catalog Number | CDS0601-NTR |
| Lot Number | 90417U126 |
| 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. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2020-03-26 |