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

Catalog Number CDS0702-XTW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Fatigue (1849); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 09/26/2023

Event Type  Injury  

Event Description

This is filed to report tissue damage and recurrent mitral regurgitation it was reported on (b)(6) 2023, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4+ and an enlarged atrium.One xtw clip was implanted, reducing mr to a grade of 1.On (b)(6) 2023, the patient returned to the hospital with symptoms of dyspnea and fatigue.Echocardiography showed a potential tissue injury to the anterior leaflet, causing mr to return to a grade of 4+.On (b)(6) 2023, an additional mitraclip procedure was performed.To treat mr, an additional xt clip was deployed laterally and successfully implanted.To further reduce mr, a second nt clip was inserted.However, before deployment, it was noted mr returned, blood pressure increased, and a tissue injury to the anterior leaflet was observed.Therefore, the clip was removed, and the procedure was discontinued.Mr remained at a grade of 4+.No additional information was provided.

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.Based on the information reviewed, a cause for the unspecified tissue injury to the anterior leaflet resulting in mitral valve insufficiency/regurgitation (recurrent) cannot be determined.The reported dyspnea and fatigue however, were cascading effects of the recurrent mr.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.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• 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: 17950672
• MDR Text Key: 325901703
• Report Number: 2135147-2023-04552
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/17/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2023
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 21214R1102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• 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