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

Catalog Number CDS0702-XTW

Device Problems Difficult to Open or Close (2921); Unintended Movement (3026)

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

Event Date 12/21/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that a mitraclip procedure was performed to treat a functional mitral regurgitation (mr) grade 4 with enlarged atrium.First clip (xtw) was placed a2/p2 centrally.During first establish final arm (efaa) test, the physician stated the clip jumped open to approximately 10 to 15-20 degrees at approximately 1/2 turn of the arm positioner from neutral position.The clip was reclosed, and the deployment process was continued.After lock line removal, the second efaa was done, and clip remained closed.However, during last deployment step, the clip opened 30-40 degrees.Leaflets remained fully inserted and the clip was stable on the leaflets, but residual mr jet lateral to clip increased slightly (from 1 to 2).Second clip (xtw) was positioned at the residual mr jet a1/p1, reducing mr to grade 1-2.The patient is reported to be stable and was moved to recovery.

Manufacturer Narrative

All available information was investigated and the reported clip opens while locked, clip open during efaa, and clip jumping could not be tested 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 opens while locked, clip open during efaa, and clip jumping.The reported unexpected medical intervention was a result of case-specific circumstance as another clip was implanted due to the clip open while locked and to further reduce mitral regurgitation.There is no indication of a product 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: 18503927
• MDR Text Key: 332788999
• Report Number: 2135147-2024-00228
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 02/13/2024

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: CDS0702-XTW
• Device Lot Number: 30919R1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2023
• 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
• Patient Outcome(s): Required Intervention