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  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+ and a posterior leaflet overriding the anterior leaflet.The clip was inserted and placed on the valve.However, while establishing final arm angle (efaa), it was observed the clip continuously opened.Troubleshooting was performed, but the issue continued to occur.Therefore, the clip was removed and replaced.One clip was then deployed on the mitral valve, reducing mr to a grade of 1-2.There were no adverse patient effects and no clinically significant delay in the procedure.

Manufacturer Narrative

All available information was investigated and the reported clip open during efaa was not confirmed via returned device 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 did not indicate a lot-specific quality issue.The investigation was unable to determine a cause for the reported clip open during efaa.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

N/a.

• 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 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: 19181758
• MDR Text Key: 341045932
• Report Number: 2135147-2024-01837
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)250102(10)40104R1108
• 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,Followup
• Report Date: 05/20/2024

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: 40104R1108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2024
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 87 KG