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 UNK CDS manufactured by Abbott Vascular.
[185000671]
Date of event - estimated. The unique device identifier (udi) is unknown because the part and lot numbers were not provided. Date of implant - estimated. The devices were not returned for analysis and a review of the lot history record and similar complaint review could not be performed as the part and lot information was not provided. This event was further reviewed by an abbott vascular medical affairs director, the reviewer stated that "in a research article titled 'predictors of left ventricular reverse remodeling after percutaneous therapy for mitral regurgitation with the mitraclip system', 374 patients were enrolled, 50 died within 12 months of the procedure and 160 others were excluded from the final analysis due to missing measurements or major medical events. One partial clip detachment after discharge and two clip detachments of unspecified nature following discharge were reported. No individual patient information is available but the reported complication rate is very low and does not raise any concern regarding the benefit/risk ratio of the mitraclip device. The reported 12 month mortality rate of 13% is within the expected range for this population. Based on the information provided a conclusive cause for the reported intraprocedure incomplete coaptations cannot be determined. There is no indication of a product issue with respect to manufacture, design, or labeling. The death, mitral regurgitation, tricuspid regurgitation, mitral stenosis, heart failure, re-hospitalization, medical intervention, and surgical intervention referenced are filed under separate medwatch reports. Literature attachment: predictors of left ventricular reverse remodeling after percutaneous therapy for mitral regurgitation with the mitraclip system.
Patient Sequence No: 1, Text Type: N, H10
[185000672]
This is filed to report the single leaflet device attachment (slda). It was reported through a research article identifying mitraclip that may be related to the following: death, mitral regurgitation, tricuspid regurgitation, mitral stenosis, heart failure, re-hospitalization, medical intervention, surgical intervention and single leaflet device attachment (slda). Details are listed in the attached article, titled? Predictors of left ventricular reverse remodeling after percutaneous therapy for mitral regurgitation with the mitraclip system.? See article for additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02918 |
| MDR Report Key | 9881804 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-25 |
| Date of Event | 2011-01-01 |
| Date Mfgr Received | 2020-03-03 |
| 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 | UNK CDS |
| 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 | 2020-03-26 |