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

Catalog Number	CDS0601-NTR
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	06/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on may 22, 2024, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4+ and an anterior prolapse.Two clips were implanted, reducing mr to a grade of 3.On (b)(6) 2024, echocardiography showed mr had increased to a grade of 4+.On (b)(6) 2024, it was discovered that both implanted clips had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).A second mitraclip procedure was performed to stabilize the slda's.However, the clip was unable to be implanted; therefore, the procedure was discontinued.It was noted an atrial septal defect (asd) was observed and was caused by the steerable guide catheter (sgc) from the initial procedure.No treatment was performed to treat the asd.On (b)(6) 2024, mitral valve replacement was performed.
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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, a cause for the reported slda could not be conclusively determined.The reported mr and tissue injury are cascading events of the slda.The reported patient effects of mitral regurgitation and tissue injury, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported surgical intervention, hospitalization, and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality 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: 19705400
• Report Number: 2135147-2024-03309
• Device Sequence Number: 12760174
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: (01)08717648226342(17)240629(10)30630R1029
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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: 06/29/2024
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 30630R1029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2023
• 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: Unknown