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

Catalog Number CDS0705-XTW

Device Problem Incomplete Coaptation (2507)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 02/08/2024

Event Type  Injury  

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 a cause for the reported slda cannot be determined.Mitral valve insufficiency/ regurgitation appears to be due to the slda.Mitral regurgitation is listed in the instructions for use (ifu) as a known possible complication 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.

Event Description

It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat a functional mitral regurgitation (mr) with grade of 4 and restricted posterior leaflet.One clip was implanted, reducing mr to grade <1.On (b)(6) 2024, the clip was observed to detach from the posterior leaflet (single leaflet device attachment (slda)).Mr increased to grade 3.On (b)(6) 2024, the patient underwent additional mitraclip procedure to stabilize the slda clip and reduce recurrent mr of grade 3.Two clips (xt and nt) were implanted on the lateral side of the slda clip, reducing mr to grade 1.There was no clinically significant delay in the procedure and no adverse patient effects.

• 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: 18768894
• MDR Text Key: 336124291
• Report Number: 2135147-2024-00849
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 31016R1031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2023
• 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 Age: 74 YR
• Patient Sex: Male