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

Catalog Number	CDS0701-NTW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	07/02/2023
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.The investigation was unable to determine a cause for the reported recurrent mitral regurgitation (mr).Mr is listed in the instructions for use as a known possible complication associated with the mitraclip procedures.The reported hospitalization was a result of case specific circumstance.There is no indication of a product issue with respect to manufacture, design or labeling.
Event or Problem Description
This report is being filed due to recurrent mitral regurgitation deemed device related.Crd_1002 - expand g4 phase 1 and phase 2 study.Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with functional mitral regurgitation (mr) with hypertrophic cardiomyopathy and leaflet tethering.Two mitraclips were implanted, reducing the mr to grade 1+.There was no device deficiency.On (b)(6) 2023, recurrent mr was noted the most recent echocardiogram showed mr grade 1-2+.The event required hospitalization, however, there was no treatment provided.There was no device deficiency.No additional information was provided regarding this issue.
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.The investigation was unable to determine a cause for the reported recurrent mr and mitral stenosis.Mr and mitral stenosis are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization was a result of case specific circumstance.There is no indication of a product issue with respect to manufacture, design or labeling.
Event or Problem Description
(b)(6) - expand g4 phase 1 and phase 2 study.Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with functional mitral regurgitation (mr) with hypertrophic cardiomyopathy and leaflet tethering.Two mitraclips ((b)(6)) were implanted, reducing the mr to grade 1+.There was no device deficiency.On (b)(6) 2023, recurrent mr was noted.The most recent echocardiogram showed mr grade 1-2+.The event required hospitalization, however, there was no treatment provided.There was no device deficiency.Subsequent to the previous report, the additional information was obtained (can wait for qe update for the fu mdr report): on (b)(6) 2023, while following up with heart failure clinic, a routine echocardiogram was performed, and moderate mitral valve stenosis was diagnosed.There remains no device malfunction.No treatment 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: 17758862
• Report Number: 2135147-2023-04018
• Device Sequence Number: 6618204
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: (01)08717648230967(17)220210(10)10205U342
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/10/2022
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 10205U342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1 IMPLANTED MITRACLIP
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 101 KG