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

Catalog Number	CDS0701-XT
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	04/06/2023
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 reported recurrent mr was due to progression of disease.The reported patient effect of mitral regurgitation, as listed in the mitraclip system instructions for use (ifu), 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
This is filed to report recurrent mitral regurgitation.It was reported that on (b)96) 2023, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4.Two clips were deployed on the mitral valve, reducing mr to a grade of 1.At the one month follow up, echocardiography showed mr had slightly increased to a grade of 1-2.Roughly five months later, an additional follow up echocardiography showed mr had increased to a grade of 4.It was noted that both clips remained stable on both leaflets.No additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• 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: 17750716
• Report Number: 2135147-2023-03987
• Device Sequence Number: 7172669
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: 08717648230981
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 09/14/2023

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: 11/02/2023
• Device Catalogue Number: CDS0701-XT
• Device Lot Number: 21103R1017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• 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: Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White