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

Catalog Number CDS0702-XT

Device Problems Entrapment of Device (1212); Difficult to Open or Close (2921)

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

Event Date 03/12/2024

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 patient presented with grade 4 degenerative mitral regurgitation (mr) and a restricted posterior leaflet for a mitraclip procedure.The second clip (xt) was grasping the leaflets, when it was noted that both grippers could not be lowered.Several attempts to lower the grippers were unsuccessful.Troubleshooting, such as; trying to lower the grippers half way and fully, and locking and unlocking was performed.The second clip was unable to invert and move back to the left atrium, due to the close proximity of the previously implanted clip and it became entangled in the chordae.There was no clip-to-clip interaction.Standard troubleshooting was performed to attempt to free the second clip, but it could be untangled.The clip was deployed on both leaflets and chordae where it was stuck.The mr was reduced to grade 1-2.There was no clinically significant delay or injury to the anatomy.

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, and a cause for the reported gripper actuation issue with both the grippers cannot be determined.The reported entrapment of device (clip becoming in anatomy) appears to be related to procedural conditions and due to the space as the previously implanted clip was in close proximity.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.

• 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: 19037722
• MDR Text Key: 339320411
• Report Number: 2135147-2024-01505
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230998
• UDI-Public: (01)08717648230998(17)240925(10)30927R1117
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/17/2024

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-XT
• Device Lot Number: 30927R1117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2023
• 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: MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention