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

Catalog Number CDS0701-XTW

Device Problems Entrapment of Device (1212); Incomplete Coaptation (2507)

Patient Problems Cardiogenic Shock (2262); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 10/14/2023

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 identified no other complaints reported from this lot.Based on available information, the cause of the reported entrapment of device (clip caught on chordae) appears to be due to the user technique.The reported incomplete coaptation is a cascading effect of the reported entrapment of device (clip caught on chordae).The reported tissue injury, mr is a cascading effect of the reported incomplete coaptation.The reported cardiogenic shock was a cascading effect of the reported mr.Additionally, the reported patient effects of tissue injury and mitral regurgitation are listed in the instructions for use, and are known possible complications associated with mitraclip procedures.The reported hospitalization and medical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that on (b)(6) 2023, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 3-4.A mitraclip xtw was implanted without issues reducing mr to <1.On (b)(6)2023, the patient experienced cardiogenic shock.An echocardiogram was performed which revealed recurrent mitral regurgitation (mr) grade 4, a leaflet tear, and that the clip had detached from the posterior mitral leaflet (pml) resulting in a single leaflet device attachment (slda).Imaging suggested there was chordal entrapment on the anterior leaflet.To stabilize the slda, two mitraclip xt devices were implanted.The mr was reduced to grade 1.Within twelve hours post procedure, the cardiogenic shock resolved.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: 18073298
• MDR Text Key: 327400793
• Report Number: 2135147-2023-04869
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2023

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 Expiration Date: 05/29/2024
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 30531R1008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2023
• Initial Date FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2023
• 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; Hospitalization