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

Catalog Number	CDS0701-XTW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Mitral Valve Stenosis (1965)
Date of Event	08/14/2024
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.Based on available information, the cause of the reported mitral stenosis was unable to be determined.The reported patient effect of mitral stenosis, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
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 degenerative mitral regurgitation (mr) grade 4+ with bileaflet prolapse.Two mitraclips were implanted, reducing the mr to grade 2+.On 14aug2024, mitral valve stenosis was diagnosed.No treatment was provided.There was no device malfunction, and the event was deemed unrelated to the device.Although deemed unrelated, this event was conservatively captured against the mitraclip device as it is a new condition post implant.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• 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: 20211686
• Report Number: 2135147-2024-04480
• Device Sequence Number: 15404000
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2024

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: 05/06/2022
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 10506R282
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2021
• 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: Other
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 76 KG