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 02/22/2024

Event Type  malfunction  

Event Description

It was reported this was a mitraclip procedure to treat tricuspid regurgitation (tr) with a grade of 5, a retracted septal leaflet, and friable anterior leaflet.It was noted imaging was challenging and one clip was previously implanted.That implanted clip had detached from the septal leaflet leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).To stabilize the slda, two clips were successfully implanted.However, after deployment of the second clip, it detached from the anterior leaflet and remained attached to the septal leaflet (slda).No additional clips were implanted and tr was reduced to a grade of 2.There was no clinically significant delay in the procedure and no adverse patient effects occurred.

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 did not indicate a lot-specific quality issue.Based on available information, the reported incomplete coaptation (single leaflet device attachment/slda), associated with the clip detachment from the anterior leaflet, was due to pre-existing patient anatomy as per the physician.The reported image resolution poor was associated with challenging image acquisition during the procedure.The reported off-label use was associated with using the mitraclip device for tricuspid valve repair.It should be noted that the mitraclip instructions for use (ifu) states, ¿the mitraclip g4 system is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation due to primary abnormality of the mitral apparatus.¿ 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 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: 18903087
• MDR Text Key: 337665043
• Report Number: 2135147-2024-01117
• 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: 03/14/2024

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: 31106R1120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2023
• 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: IMPLANTED MITRACLIP (X2); STEERABLE GUIDE CATHETER
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 122 KG