MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 01/01/2013

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Dates estimated.The udi number is not known as the part and lot number were not provided.The additional patient effects reported in the article are captured under a separate medwatch report number.Attachment: article titled, " usefulness of computed tomography to predict residual mitral regurgitation after transcatheter mitral valve edge-to-edge repair.".

Event Description

This is filed to report patient death.This research article was a retrospective study designed to evaluate preprocedural parameters associated with residual mitral regurgitation (mr) after mitraclip implantation by using multidetector computed tomography (mdct), identify optimal cut-off values and assess the impact on outcomes.Complications observed during the study period include death, recurrent mitral regurgitation, heart failure, re-intervention, mitral valve replacement and hospitalization.In conclusion, in patients with secondary mr undergoing the mitraclip procedure, preprocedural mdct parameters, specifically mitral valve orifice area (mvoa)/mitral annulus area (maa) ratio and mitral leaflet calcification (mlc), are useful to predict postprocedural residual mr.Details are listed in the attached article titled, "usefulness of computed tomography to predict residual mitral regurgitation after transcatheter mitral valve edge-to-edge repair".No additional information was provided.

Manufacturer Narrative

The devices were not returned for analysis and a review of the lot history record could not be performed as the part/lot information was not provided.Based on the information reviewed and due to the limited information available from the article and the article covering multiple patients, a cause for the reported death cannot be determined.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15465812
• MDR Text Key: 300402846
• Report Number: 2135147-2022-01303
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Male