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

Catalog Number CDS0702-XTW

Device Problems Product Quality Problem (1506); Migration (4003)

Patient Problems Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 02/15/2024

Event Type  Injury  

Event Description

It was reported that a patient presented with grade 4 mixed mitral regurgitation (mr) for a mitraclip procedure.One clip was successfully implanted on (b)(6) 2024.The mr was reduced to grade 1.Before deployment, the clip delivery system advanced a bit in the left ventricle, which required tension to be released on the clip.The clip remained stable and well seated after deployment.On (b)(6) 2024, a transthoracic echocardiogram (tte) was performed and a leaflet tear was noted.The clip remained attached to both leaflets, but partially detached from the posterior leaflet.The mr was worsened at grade 4 and the patient experienced dyspnea.Per the physician, the partial detachment was due to how the gripper is arranged on the mitraclip and the account switched to a competitor device due to the issue.A second clip intervention was performed on (b)(6) 2024 with two nt clips successfully implanted.The mr was reduced from grade 4 to 2.

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 cause of the reported partial clip movement and tissue injury were unable to be determined.The reported gripper arrangement was due to the physician¿s opinion of the device.The reported worsening mr was a cascading event of the reported tissue injury.The reported dyspnea is a cascading event of the reported worsening mr.The reported patient effects of tissue injury, mitral regurgitation, and dyspnea, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• 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: 18877570
• MDR Text Key: 337358637
• Report Number: 2135147-2024-01072
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

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: CDS0702-XTW
• Device Lot Number: 31009R2026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2023
• 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