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

Catalog Number	CDS0701-XTW
Medical Device Problem Codes	Entrapment of Device (1212); Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Cardiogenic Shock (2262); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	10/14/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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)
• Common Device Name: 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
• Report Number: 2135147-2023-04869
• Device Sequence Number: 7815657
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2023
• Initial Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown