MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP; MITRAL VALVE REPAIR DEVICES

Model Number	CDS0701-NT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Mitral Valve Stenosis (1965); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	07/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
(b)(6) - expand g4 phase 1 and phase 2 study.Patient id: (b)(6).It was reported that on 15june2021, the patient presented with mixed mitral regurgitation (mr).Two mitraclips were successfully implanted, reducing the mr to grade 1+.There was no device deficiency.On (b)(6) 2021, severe mr was noted on the follow-up imaging.Per physician, the event was not serious, and the patients¿ symptoms had improved.On (b)(6) 2021, mitral valve stenosis was diagnosed.There was no additional treatment, no medical intervention, and no hospitalization due to the events.There remained no malfunction.
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 is a known possible complication associated with mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstance as no additional intervention or treatment was provided.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP
• 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: 21721004
• Report Number: 2135147-2025-01630
• Device Sequence Number: 9418985
• Product Code: NKM
• UDI-Device Identifier: 08717648230943
• UDI-Public: (01)08717648230943(17)220118(10)10118U104
• 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): 04/18/2025

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: 01/18/2022
• Device Model Number: CDS0701-NT
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 10118U104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2021
• 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 MITRACLIP
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 68 KG