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); Expulsion (2933)

Patient Problem Embolism/Embolus (4438)

Event Date 01/31/2024

Event Type  Injury  

Event Description

It was reported this was an off-label mitraclip procedure to treat tricuspid regurgitation (tr) with a grade of 5 and a rotated heart.It was noted imaging was difficult throughout the procedure.An xtw clip was inserted and deployed on the tricuspid valve.However, the clip expulsed and embolized to the hepatic vein.The clip was removed from the anatomy via snare and replaced.The procedure was continued, and two new xtw clips were successfully implanted, reducing tr to a grade of 4.There was no clinically significant delay in the procedure.

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 the reported image resolution poor was related to patient and procedural conditions as imaging was reported to be very challenging due to rotated heart.Slda associated with the clip detaching from the septal leaflet appears to be due to the patient conditions (large gaps with tethered leaflets) and therefore, related to off-label use.The reported off-label use of the device was associated with the mitraclip device being used on the tricuspid valve to tr.Unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.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: 18759650
• MDR Text Key: 336010494
• Report Number: 2135147-2024-00822
• Device Sequence Number: 1
• Product Code: NKM
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 30717A1060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 50 KG