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

Catalog Number CDS0706-XTW

Device Problems Entrapment of Device (1212); Product Quality Problem (1506)

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

Event Date 08/17/2023

Event Type  Injury  

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, the reported product quality problem (irregular appearance) associated with the gripper sticking out of the clip arm after deployment was due to the gripper being unintentionally entangled with the leaflet and not being freed before deployment.The cause of the reported entrapment of device associated with the gripper entanglement could not be determined.The reported image resolution poor was associated with difficult visualization.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

This is filed to report device entrapment.It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.An xtw clip was inserted, but while advancing under the valve, the anterior gripper became caught on the leaflet and was unable to be freed.Although unable to be removed from the leaflet, the clip was able to be deployed on both leaflets.It was noted after deployment, the gripper was sticking up outside the clip arms.One additional clip was implanted, reducing mr to a grade of 1.There was no clinically significant delay in the procedure.No additional information was provided.

• 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 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: 17695693
• MDR Text Key: 322798264
• Report Number: 2135147-2023-03884
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• 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
• Report Date: 09/06/2023

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: 05/23/2024
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30524R1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 65 KG