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

Catalog Number	CDS0701-NTW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	08/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4+ and a prolapsed posterior leaflet.Two mitraclip ntw clips were implanted without issues.The mr was reduced to a grade of 1+.On (b)(6) 2023, the patient returned to the hospital with recurrent mr.The implanted clips were noted to be stable.On (b)(6) 2023, mitral valve replacement was performed.During this procedure, it was observed that one of the clips had perforated one of the leaflets.No additional information was provided.
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
Subsequent to the previously reported filed report, additional information was received: on (b)(6) 2022, an echocardiogram was performed and revealed recurrent mr with a stable grade of 2-3.On (b)(6) 2023, an echocardiogram was performed and revealed recurrent mr with a grade of 4.On (b)(6) 2023, an echocardiogram was performed and revealed recurrent mr with a grade of 4.The previously implanted clips were noted to be stable on the leaflets.On (b)(6) 2023, the patient was referred for surgery.On (b)(6) 2023, during a surgical official office visit, an echocardiogram revealed recurrent mr.The implanted clips were noted to be stable.
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 cause of the reported tissue injury cannot be determined.The reported mitral regurgitation (mr) is a cascading effect of the reported tissue injury.Additionally, the reported patient effects of tissue injury and mitral regurgitation are listed in the instructions for use, and are known possible complications associated with mitraclip procedures.The reported surgical 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.

• 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: 18375396
• Report Number: 2135147-2023-05654
• Device Sequence Number: 18037131
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• 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: 2022
• Device Explanted Year: 2023
• 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): 01/29/2024

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: 03/28/2023
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 20328R164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 69 KG