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 10/31/2023

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 of both implanted clips.Mitral regurgitation is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.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.

Event Description

It was reported that on (b)(6) 2023, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade 4.After deployment of the xtw clip, the clip arms opened to roughly 30 degrees.A second clip was then implanted to help stabilize the implanted clip.Mr was reduced to a grade of 1-2.On (b)(6) 2023, the patient returned to the hospital.Echocardiography was performed and showed the two implanted clips 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.It was also noted one of the grippers of the first clip was noted to be bent.

• 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: 18888329
• MDR Text Key: 337472283
• Report Number: 2135147-2024-01094
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30530A1008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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
• Treatment: IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 72 KG