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

Catalog Number	CDS0701-XTW
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	07/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two unknown mitraclips were implanted on (b)(6) 2020.The mr was left at mild to moderate at that time.Due to recurrent mitral regurgitation, another clip was placed.There was no movement of the clips that were implanted in the first procedure.
Additional Manufacturer Narrative
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 could not be performed as no device/lot information was provided.Based on available information, a cause for the reported mitral regurgitation (mr) could not be conclusively determined.The reported patient effect of mitral regurgitation, as listed in the mitraclip instructions for use, is a known possible complication associated with [product] procedures.The reported unexpected medical intervention and hospitalization 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 a patient presented with grade 4 functional mitral regurgitation.Two xtw mitraclips were implanted on (b)(6) 2020.The mr was reduced to grade 1-2.Due to recurrent grade 3 mr, another clip was implanted on (b)(6) 2024.There was no movement of the clips that were implanted in the first procedure.Both clips remained stable on the leaflets.The mr was reduced to grade <1.No additional information was provided.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• 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: 19961419
• Report Number: 2135147-2024-03922
• Device Sequence Number: 12528901
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: (01)08717648231001(17)210312(10)00313U137
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 09/20/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2021
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 00313U137
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2020
• 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
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 88 KG