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

Catalog Number CDS0705-XTW

Device Problem Difficult to Open or Close (2921)

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

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 3+.An xtw (lot: 30731r1120) was chosen for implantation.During the gripper alignment above the valve, the posterior gripper failed to drop.Troubleshooting was attempted but was unsuccessful.The xtw was removed and a replacement mitraclip was used to complete the procedure, reducing mr to grade 1+.Outside of the patient, the posterior gripper on the xtw still was not functioning.There was no patient consequences and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported difficult to open or close (gripper actuation - single) could not be confirmed via returned device analysis.Additionally, the gripper arm cover (non-tactile) was observed to be bulky and frayed.One gripper lever assembly tab was observed to be broken.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, a cause of the reported difficult to open or close (gripper actuation - single) could not be determined as the issue was not identified in device analysis.A cause of the observed bulky and frayed gripper arm cover could not be determined.The observed broken gripper lever assembly tab appears to be related to procedural handling.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: 18588065
• MDR Text Key: 334833321
• Report Number: 2135147-2024-00379
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: UY
• 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,Followup
• Report Date: 02/21/2024

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: 30731R1120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• 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: 88 YR
• Patient Sex: Female
• Patient Weight: 65 KG