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

Catalog Number CDS0706-XTW

Device Problems Break (1069); Positioning Failure (1158); Difficult to Open or Close (2921)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/13/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat mitral regurgitation (mr).The patient presented with challenging anatomy and had a previous non-abbott clip attempt that failed.Due to the patient's condition, the transseptal puncture was not optimal but the steerable guide catheter (sgc) was still able to be steered down to the valve.An xtw (lot: 30920r2053) was then attempted to be implanted.Grasping was challenging.After two gripper cycles, the posterior gripper could not be confirmed to be lowering during simultaneous actuation.Troubleshooting was attempted but the gripper would not lower.The clip was removed from the patient.Upon inspection, the gripper line was not visible.A replacement xtw clip was used to complete the procedure, reducing mr to moderate.

• 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: 18856864
• MDR Text Key: 337117468
• Report Number: 2135147-2024-01035
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30920R2053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2023
• 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 Age: 81 YR
• Patient Sex: Female
• Patient Weight: 61 KG