MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM NT; VALVE REPAIR

Model Number	CDS0501
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This is filed to report partial clip detachment and recurrent mitral regurgitation.It was reported that on (b)(6) 2018, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with an unknown grade.Two clips were implanted, reducing mr to an unknown grade.On (b)(6) 2022, the patient returned to the hospital and imaging showed one of the implanted clips had partially detached from the posterior leaflet, causing mr to increase to a grade of 4.Therefore, an additional mitraclip was performed, and one clip was implanted, reducing mr to a grade of 1.
Additional Manufacturer Narrative
The clip remains 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.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated, and a cause for the reported migration (partial clip movement) cannot be determined.Mitral valve insufficiency/ regurgitation (mr) appears to be due to the partial clip movement (migration).Mitral regurgitation is a known possible complication associated with mitraclip procedures.Unexpected medical intervention and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM NT
• Common Device Name: VALVE REPAIR
• 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: 15699386
• Report Number: 2135147-2022-01863
• Device Sequence Number: 20950637
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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: 10/21/2018
• Device Model Number: CDS0501
• Device Catalogue Number: CDS0501
• Device Lot Number: 71021U194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2017
• 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: IMPLANTED MITRACLIP.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male