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); Swelling/ Edema (4577)

Event Date 11/02/2023

Event Type  Injury  

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 identified no similar complaints reported from this lot.The investigation determined the reported slda appears to be related to patient morphology/pathology.The worsening mr appears to be related to the slda.Dyspnea and edema appear to be cascading effects of the worsening mr.Mr, dyspnea and edema are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization and unexpected medical intervention were results of case specific circumstances there is no indication of a product issue with respect to manufacture, design or labeling.

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.One clip was implanted, reducing mr to a grade of 1<.On (b)(6) 2023, the patient returned due to shortness of breath and swelling.Echocardiography showed the implanted clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), causing mr to increase to a grade of 4+.On (b)(6) 2023 an additional mitraclip was performed, and two clips were implanted, reducing mr to a grade of 2.No additional information was provided.

• 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: 18204781
• MDR Text Key: 328917749
• Report Number: 2135147-2023-05168
• 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: 11/24/2023

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: 05/20/2024
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30522A1058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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): Required Intervention; Hospitalization
• Patient Sex: Male