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 Problems Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 03/28/2024

Event Type  Injury  

Event Description

It was reported on (b)(6) 2023, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4.One xtw clip was implanted, reducing mr to a grade of 2.Roughly one year post procedure, the patient returned to the hospital for a follow up with a symptom of shortness of breath.Echocardiography showed the implanted clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), causing mr to return to a grade of 4.It was noted tissue damage potentially occurred.On (b)(6) 2024, an additional mitraclip procedure was performed.To stabilize the slda, two additional xt clips were implanted, reducing mr to a grade of 1.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated, and the reported slda appears to be related to patient conditions as the physician believed there was a change in anatomy.Unspecified tissue injury and mitral valve insufficiency/ regurgitation (recurrent) resulting in dyspnea appear to be due to the slda.Mitral regurgitation, dyspnea and tissue damage are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Unexpected medical intervention and hospitalization were a result of case-specific circumstances.There is no indication of a product 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 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: 19197235
• MDR Text Key: 341234838
• Report Number: 2135147-2024-01872
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)240104(10)30104R2097
• 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: 04/26/2024

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: 01/04/2024
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30104R2097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2023
• 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