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

Catalog Number CDS0706-NTW

Device Problems Premature Activation (1484); Difficult to Remove (1528); Difficult to Open or Close (2921); Physical Resistance/Sticking (4012)

Patient Problem Embolism/Embolus (4438)

Event Date 10/11/2023

Event Type  Injury  

Event Description

It was reported a mitraclip procedure was being performed to treat grade 4 mitral regurgitation (mr).Placement of the first clip was completed without issue.A second clip was placed, and upon attempting to open the clip, it was difficult.Troubleshooting was performed at which point it was noted that the white knob had some unusual stiffness.The physician decided to retrieve the clip, however they were unable to retract the clip back into the guide.As they attempted to pull it back, the clip detached from the mandrel and the lockline had detached.The physician opted to abort the procedure, and a surgeon was called to retrieve the clip.No clip was implanted and mr remained at 4.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

All available information was investigated and the reported physical resistance of the arm positioner was not confirmed via returned device analysis.The reported difficult to remove the clip delivery system (cds) from the guide, inability to open the clip, and premature activation could not be replicated in a testing environment as the clip was returned detached with damage clip components and the coupler was 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 identified no other complaints reported from this lot.The investigation was unable to determine a cause for the reported difficulty opening the clip, resistance of the arm positioner, and difficult removing the cds from the guide.The reported premature activation (clip detached from mandrel) appears to be due to the identified broken coupler.The broken coupler appears to be due to the troubleshooting maneuvers to remove the cds from the guide.The reported embolism was due to the premature activation.Embolism is listed in the instructions for use as known a possible complication associated with mitraclip.The reported surgical intervention and removal of foreign body were results 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 (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: 18065900
• MDR Text Key: 327292172
• Report Number: 2135147-2023-04851
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037435
• UDI-Public: 05415067037435
• 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,Followup
• Report Date: 12/19/2023

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 Expiration Date: 06/03/2024
• Device Catalogue Number: CDS0706-NTW
• Device Lot Number: 30601A1036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2023
• 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
• Patient Age: 81 YR
• Patient Sex: Male