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

Catalog Number CDS0601-XTR

Device Problem Incomplete Coaptation (2507)

Patient Problems Angina (1710); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 12/01/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4+, enlarged atrium, and relatively small mitral valve orifice.A mitraclip xtr was implanted without issues, reducing he mr to a grade of 2-3.On december 1, 2023, the patient presented with symptoms of chest tightness.On january 7, 2024, an echocardiogram was performed and revealed recurrent mitral regurgitation (mr) with a grade of 4+ and that the previously implanted mitraclip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).On (b)(6) 2024, a mitral valve replacement was performed.

Manufacturer Narrative

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 did not indicate a lot specific issue.Based on available information, the cause of the reported agnia cannot be determined.The cause of the reported incomplete coaptation is due to the patient anatomy (thickened leaflets).The reported mitral regurgitation (mr) appears to be a cascading effect of the reported incomplete coaptation.Additionally, the reported patient effect of mitral regurgitation and agnia are listed in the instructions for use, and are known possible complications associated with mitraclip procedures.The reported surgical intervention and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP XTR 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: 18624004
• MDR Text Key: 334333492
• Report Number: 2135147-2024-00450
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: 08717648226366
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2024
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 30503R1068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2023
• 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): Hospitalization; Required Intervention