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

Catalog Number UNK CDS

Device Problem Incomplete Coaptation (2507)

Patient Problems Tricuspid Regurgitation (2112); Pericardial Effusion (3271)

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event - estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Implant date - estimated.The clips remain in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The other patient events listed in the article are filed under separate medwatch report numbers.Attached literature title : tricuspid regurgitation after transcatheter mitral valve repair: clinical course and impact on outcome.

Event Description

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: patient deaths, recurrent tricuspid regurgitation, pericardial effusion, and medical intervention.Device issues include, single leaflet device attachment (slda).Details are listed in the attached article, titled ¿tricuspid regurgitation after transcatheter mitral valve repair: clinical course and impact on outcome.¿ please see article for additional information.

Manufacturer Narrative

The devices were not returned for analysis.A review of the lot history records could not be performed due to unknown lot information.Additionally, a review of the complaint histories could not be performed due to unknown lot information.Based on the information reviewed, the cause for the reported single leaflet device attachment/sldas could not 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 VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11305604
• MDR Text Key: 232357060
• Report Number: 2024168-2021-01051
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 03/02/2021
• Supplement Dates FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR