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

Catalog Number CDS0705-XTW

Device Problem Incomplete Coaptation (2507)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 02/19/2024

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 did not indicate a lot-specific quality issue.The investigation determined the reported slda appears to be related to patient morphology/pathology.The recurrent mr appears to be related to the slda.Mr is listed in the instructions for use as a known possible complication associated with the mitraclip procedures.The reported hospitalization and unexpected medical intervention were results of case specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

It was reported that on 19feb2024, a patient presented with grade 4 functional mitral regurgitation (mr) for a mitraclip procedure.One mitraclip xtw was implanted and the mr was reduced to grade 2.On 20feb2024, a transthoracic echocardiogram (tte) displayed a single leaflet device attachment (slda) and recurrent grade 3+ mr.The posterior leaflet was detached.Per the physician, the slda was due to the clip being too close to the lateral indentation and grasped in the indentation area.On 26feb2024, a second clip intervention was performed.An xt was place medial to the slda on anterior 2 and posterior 2 leaflet segments (a2/p2).There was residual mr from the lateral indentation.The mr was reduced to grade 2+.The procedure was successful.No additional information was provided.

• 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: 18878148
• MDR Text Key: 337409563
• Report Number: 2135147-2024-01075
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 31016R1055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2023
• 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
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 46 KG