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

Catalog Number CDS0705-XTW

Device Problems Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Unintended Movement (3026)

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

Event Date 03/13/2024

Event Type  malfunction  

Event Description

It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.An xtw clip was inserted into the mitral valve.However, while steering down to the valve, the clip moved in an unintended direction.This occurred during adjusting to the center of a2p2 and checking the trajectory.It was noted that the clip was curved more than 90 degrees.Per ifu, the clip delivery system should not curve more than 90 degrees.Therefore, the clip was removed and replaced.Upon removal of the clip, the dc shaft observed to be bent.One clip was then implanted, reducing mr to a grade of 1+.There were no adverse patient effects and 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 and without the device to analyze, the cause of the reported sleeve steering issues and the bent dc shaft were unable to be determined.The reported improper or incorrect procedure or method was associated with the user curving more than 90 degrees.It should be noted that the mitraclip instructions for use (ifu) states ¿warning: do not deflect the sleeve tip more than 90 degrees as device damage may occur.¿ there is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• 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: 19034211
• MDR Text Key: 339283511
• Report Number: 2135147-2024-01491
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648288647
• UDI-Public: (01)08717648288647(17)241030(10)31031R1051
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2024

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: CDS0705-XTW
• Device Lot Number: 31031R1051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2023
• 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: 84 YR
• Patient Sex: Female
• Patient Weight: 26 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian