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

Catalog Number CDS0706-XTW

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2024

Event Type  malfunction  

Event Description

It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.An xtw clip was inserted and while establishing final arm angle (efaa), the clip opened to roughly degrees.Therefore, the clip was removed and replaced.The procedure was continued, and a new xtw clip was successfully implanted, reducing mr to a grade of 1-2.There were no adverse patient effects and no clinically significant delay in the procedure.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• 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: 19181870
• MDR Text Key: 341079661
• Report Number: 2135147-2024-01839
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)241217(10)31219A1007
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 31219A1007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2023
• 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: STEERABLE GUIDE CATHETER
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 87 KG