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

Catalog Number CDS0706-XTW

Device Problems Premature Activation (1484); Difficult to Remove (1528); Material Separation (1562); Difficult to Open or Close (2921)

Patient Problem Embolism/Embolus (4438)

Event Date 03/13/2024

Event Type  Death  

Event Description

It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+ and a restricted posterior leaflet.One clip was inserted and successfully implanted.To further reduce mr, a second xtw clip was inserted.Due to the gradient, the physician decided to remove the clip, and the procedure was discontinued.However, while retracting the clip into the steerable guide catheter (sgc), resistance was felt.The physician pushed the clip out of the sgc, and it jumped open.The clip was attempted to be closed, however, the grippers would not fully lower.The clip appeared to have detached from the clip delivery system (cds) and remained attached only to the lock line.One of the grippers then detached and embolized into the left ventricle (lv) and became caught in the chordae.Open surgery was performed, and the gripper was able to be removed from the anatomy.Mr reduced to a grade of 2-3.There was no clinically significant delay in the procedure.

Manufacturer Narrative

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

Manufacturer Narrative

B2 - death date is estimated.

Event Description

It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+ and a restricted posterior leaflet.One clip was inserted and successfully implanted.To further reduce mr, a second xtw clip was inserted.Due to the gradient, the physician decided to remove the clip, and the procedure was discontinued.However, while retracting the clip into the steerable guide catheter (sgc), resistance was felt.The physician pushed the clip out of the sgc, and it jumped open.The clip was attempted to be closed, however, the grippers would not fully lower.The clip appeared to have detached from the clip delivery system (cds) and remained attached only to the lock line.One of the grippers then detached and embolized into the left ventricle (lv) and became caught in the chordae.There were no patient symptoms observed at the time.Open surgery was performed, and the gripper was able to be removed from the anatomy.Mr reduced to a grade of 2-3.There was no clinically significant delay in the procedure.

• 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: 19035196
• MDR Text Key: 339283378
• Report Number: 2135147-2024-01494
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)241118(10)31115A2056
• 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: 04/29/2024

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: CDS0706-XTW
• Device Lot Number: 31115A2056
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/20/2023
• 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: IMPLANTED MITRACLIP.; STEERABLE GUIDE CATHETER.
• Patient Outcome(s): Death; Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female