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

Catalog Number CDS0706-XTW

Device Problems Off-Label Use (1494); Incomplete Coaptation (2507)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

It was reported a mitraclip procedure was performed to treat functional mitral regurgitation (mr) and tricuspid regurgitation (tr) with a grade of 5+.A steerable guide catheter (sgc) was inserted and three clips were successfully deployed on the mitral valve without issues.The sgc was then retracted into the right atrium (ra) and one mitraclip was deployed on the tricuspid valve.However, after deployment, it was suspected the clip detached from the anterior leaflet and remained attached to the septal leaflet (single leaflet device attachment/slda).Tr was reduced to a grade of 3-4 and no additional treatment was performed.After removal of the sgc, a left to right shunt was observed.Therefore, an atrial sept defect (asd) closure device was implanted.No clinically significant delay in the procedure.

Manufacturer Narrative

The device was not returned for 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 identified no similar complaints reported from this lot.Based on available information, the cause of the reported slda was unable to be determined.The reported off-label use was associated with the use of the mitraclip device on the tricuspid valve.There is no indication of a product quality issue with respect to manufacture, design, or labeling the additional mitraclip device referenced in b5 is being filed under a separate medwatch report.H6: device code 1494 - indication for use (use in tricuspid valve).

• 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: 18580212
• MDR Text Key: 334065844
• Report Number: 2135147-2024-00352
• 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: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• 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: 31003A2065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2023
• 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: 88 YR
• Patient Sex: Female
• Patient Weight: 65 KG