MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR); MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0706-XTW

Device Problem Incomplete Coaptation (2507)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2024

Event Type  Injury  

Event Description

It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4, posterior prolapse, and flail.An xtw clip was inserted and deployed on the mitral valve.However, after deployment, the clip detached from one leaflet and remained attached to the other leaflet (single leaflet device attachment/slda).To stabilize the slda, an additional clip was implanted, reducing mr to a grade of 1-2.There was no clinically significant delay in the procedure.

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 quality issue.Based on available information, the cause of the reported slda was unable to be determined.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18557959
• MDR Text Key: 333438139
• Report Number: 2135147-2024-00319
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30607A2002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2023
• 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
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention