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 Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 12/06/2023

Event Type  Injury  

Manufacturer Narrative

The clip remains in the patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2023, a mitraclip procedure was performed to treat mitral regurgitation (mr).An unknown mitraclip was implanted.At the 30 day follow up, the mitraclip was observed to be detached from one leaflet (single leaflet device attachment (slda)) resulting in recurrent mr.On (b)(6) 2023 ,the patient underwent mitral valve replacement surgery.The patient is reported to be stable.The physician thought the slda was related to the patient's functional anatomy.No additional information was provided.

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.All available information was investigated, and the reported single leaflet device attachment (slda) per the physician is related to patient anatomy.The reported mr is a cascading effect of the reported incomplete coaptation.Additionally, the reported patient effect of mitral regurgitation is listed in the instructions for use, and is a known possible complication associated with mitraclip procedures.The reported hospitalization and surgical intervention 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 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: 18411225
• MDR Text Key: 331526268
• Report Number: 2135147-2023-05763
• 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,Followup
• 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 Expiration Date: 08/09/2023
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 20809A1038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• 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
• Patient Sex: Female