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	10/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: the udi number is not known as the part and lot numbers were not provided implant date was estimated.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
This report is being filed due to mitral valve insufficiency requiring a mitral valve replacement.It was reported that on an unspecified date, a mitraclip procedure had been performed placing a mitraclip (s).On (b)(6) 2023, the patient was presented to the emergency department with severe mitral and tricuspid valve insufficiency.Medications were provided.Consultation with the cardiothoracic surgeon was performed and a mitral valve replacement (mvr) and tricuspid valve replacement (tvr) were recommended.A left atrial appendage (laa) clip was also recommended for stroke prevention.On (b)(6) 2023, the mvr, tvr, along with the laa clip procedures were performed.Both valves had a non-abbott bioprosthesis placed.The event resolved.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record could not be performed as the lot information regarding the complaint device was not provided.Based on the information reviewed a cause for the mitral valve insufficiency/ regurgitation (recurrent) cannot be determined.Mitral regurgitation is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.Hospitalization, medication required and surgical intervention were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.D6a: estimated date updated to actual date.
Event or Problem Description
Subsequent to the initial report, the additional information as received: it was reported that on (b)(6) 2021, a mitraclip procedure was performed for severe degenerative mitral regurgitation (mr) with a myxomatous barlow mitral valve and prolapsed leaflets.Two mitraclips (xtw and xt) were implanted without a device issue reported, reducing the mr to mild-moderate.The procedure was deemed successful without complications.

• 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: 18179118
• Report Number: 2135147-2023-05110
• Device Sequence Number: 12675890
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: 08717648230981
• 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: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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 Catalogue Number: CDS0701-XT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 1 IMPLANTED MITRACLIP; THREE TRICLIPS
• Outcome Attributed to Adverse Event: Disability; Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian