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

Catalog Number	CDS0701-XT
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Mitral Valve Insufficiency/ Regurgitation (4451); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
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 investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that during a presentation a mitraclip procedure was reviewed.The xtw clip was surgically explanted.The clip arms were opened to approximately 50 degrees.It was hypothesized that the tension from the valve leaflet and failure of the clip lock mechanism contributed to the opening of the xtw.
Event or Problem Description
It was reported that on (b)(6) 2022, a patient presented with grade 4+ degenerative mitral regurgitation (mr), tricuspid regurgitation, insulin-dependent diabetes mellitus (iddm), cardiomyopathy, history of coronary artery bypass graft (cabg), chronic obstructive pulmonary disease (copd) and a posterior 2 prolapse.Three clips were implanted, two xtws and an xt.The mr was reduced to grade 1+.On (b)(6) 2023, the patient returned symptomatic with grade 4+ mr, fatigue, and shortness of breath.An echocardiogram was performed, displaying the central xt clip opened to approximately 50 degrees.The xt was stable between the 2 xtw clips that were placed lateral to each side.On (b)(6) 2023 the clips were surgically explanted and a valve replacement was performed.On (b)(6) 2024, a presentation of the procedure was performed by dr.(b)(6).The clips were surgically explanted.The xt clip arms were opened to approximately 50 degrees.It was hypothesized that the tension from the valve leaflet and failure of the clip locking mechanism contributed to the opening of the xt.During the presentation, the opened clip was incorrectly labeled as an xtw.It was confirmed by the implanter that the clip that had opened was an xt.No additional information was provided.
Additional Manufacturer Narrative
The device is included in the correction notice issued by abbott on 06sep2022 for clips not being able to establish final arm angle(efaa) and/or clip opening while locked (cowl) with the mitraclip and triclip delivery system(s).Correction: e1: dr.(b)(6) (the presenter) was replaced with dr.(b)(6), who was the implanting physician.H6 - adverse event problem: health effect - clinical code: 4582 was removed.
Event or Problem Description
It was reported that on (b)(6) 2022, a patient presented with grade 4+ degenerative mitral regurgitation (mr), tricuspid regurgitation, insulin-dependent diabetes mellitus (iddm), cardiomyopathy, history of coronary artery bypass graft (cabg), chronic obstructive pulmonary disease (copd) and a posterior 2 prolapse.Three clips were implanted, two xtws and an xt.The mr was reduced to grade 1+.On (b)(6) 2023, the patient returned symptomatic with grade 4+ mr, fatigue, and shortness of breath.An echocardiogram was performed, displaying the central xt clip opened to approximately 50 degrees.The xt was stable between the 2 xtw clips that were placed lateral to each side.On 05may2023 the clips were surgically explanted and a valve replacement was performed.On (b)(6) 2024, a presentation of the procedure was reviewed.The clips were surgically explanted.The xt clip arms were opened to approximately 50 degrees.It was hypothesized that the tension from the valve leaflet and failure of the clip locking mechanism contributed to the opening of the xt.During the presentation, the opened clip was incorrectly labeled as an xtw.It was confirmed by the implanter that the clip that had opened was an xt.
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 did not indicate a lot-specific quality issue.The investigation was unable to determine a cause for the reported clip opened while locked.The reported patient effect of recurrent mr appears to be related to the clip opening.Dyspnea and fatigue appear to be cascading effects or the recurrent mr.Mr, dyspnea, and fatigue are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization and surgical intervention were results of case specific circumstances as the patient returned to the hospital and the clips were surgically explanted and a valve replacement was performed.There is no indication of a product 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: 20977477
• Report Number: 2135147-2024-06477
• Device Sequence Number: 11811164
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: (01)08717648230981(17)230307(10)20308R162
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2025

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: 03/07/2023
• Device Catalogue Number: CDS0701-XT
• Device Lot Number: 20308R162
• 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: 11/25/2024
• Supplement Date Received by Manufacturer: 12/30/2024; 02/04/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 01/22/2025; 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2024168-9/6/2022-003-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 74 KG