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

Catalog Number CDS0706-XT

Device Problems Break (1069); Unintended Movement (3026)

Patient Problems Foreign Body In Patient (2687); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 01/25/2024

Event Type  Injury  

Manufacturer Narrative

The clip remains in the patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2023, a patient presented with grade 4 denergative mitral regurgitation (mr) and calcification on the anterior leaflet for a mitraclip procedure.Two mitraclip xts were implanted in the patient.The procedure went well, and there were no adverse effects.The mr was reduced to grade <1.A post-procedural transesophageal echocardiogram (tee) was performed, which displayed some device settling of one of the clips (30324r1115).Per the physician, the device settling was not at a degree to affect the mr grade.On (b)(6) 2024, the patient presented with severe (grade 4) mr.It was noted that both the implanted clips had opened and the gripper on one clip was missing.Surgery was performed and the two clips were removed and a mitral valve replacement was performed.Per the physician, this was delayed opening of both clips and he felt this was different than the original 'clip opened while locked' (cowl) issues identified by the field.The patient is stable and recovering well.

• 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: 18721110
• MDR Text Key: 335581694
• Report Number: 2135147-2024-00712
• Device Sequence Number: 1
• Product Code: NKM
• 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: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2024
• Device Catalogue Number: CDS0706-XT
• Device Lot Number: 30324R1116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2023
• 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
• Patient Outcome(s): Required Intervention