BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP CLIP DELIVERY SYSTEM

    MDR report key: 10005956 · Received April 28, 2020

    Report

    Report Number
    2024168-2020-03955
    Event Type
    Death
    Date Received
    April 28, 2020
    Date of Event
    January 1, 2019
    Report Date
    July 30, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA.

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE LOT HISTORY RECORD AND SIMILAR COMPLAINT REVIEW COULD NOT BE PERFORMED AS THE PART AND LOT INFORMATION REGARDING THE COMPLAINT DEVICE WAS NOT PROVIDED. ADDITIONALLY, DUE TO THE LIMITED INFORMATION AVAILABLE, AND THIS ARTICLE COVERING SEVERAL PATIENTS ACROSS DIFFERENT SITES, A CAUSE FOR THE PATIENT EFFECTS OF DEATH (NON-CARDIOVASCULAR DEATH, CARDIAC DEATH AND/OR VASCULAR DEATH) COULD NOT BE DETERMINED. THE REPORTED PATIENT EFFECT OF DEATH AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI NUMBER IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. LITERATURE TITLED, MULTISOCIETY EXPERT CONSENSUS SYSTEMS OF CARE DOCUMENT 2019 AATS/ACC/SCAI/STS EXPERT CONSENSUS SYSTEMS OF CARE DOCUMENT: OPERATOR AND INSTITUTIONAL RECOMMENDATIONS AND REQUIREMENTS FOR TRANSCATHETER MITRAL VALVE INTERVENTION.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT DEATH. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING MITRACLIP DEVICES THAT MAY BE RELATED TO: SINGLE LEAFLET DEVICE ATTACHMENT/SLDA, COMPLETE CLIP DETACHMENT, HEART FAILURE, DEATH, CARDIAC ARREST, EMBOLISM, FOREIGN BODY, HEMORRHAGE, TRANSIENT ISCHEMIC ATTACK, RECURRENT MITRAL REGURGITATION, WORSENING MITRAL REGURGITATION, MITRAL STENOSIS WHICH RESULTED IN PROLONGED HOSPITALIZATION, MEDICAL INTERVENTION, SURGICAL INTERVENTION.. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED, "MULTISOCIETY EXPERT CONSENSUS SYSTEMS OF CARE DOCUMENT 2019 AATS/ACC/SCAI/STS EXPERT CONSENSUS SYSTEMS OF CARE DOCUMENT: OPERATOR AND INSTITUTIONAL RECOMMENDATIONS AND REQUIREMENTS FOR TRANSCATHETER MITRAL VALVE INTERVENTION." NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471247 MITRACLIP CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR UNK N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death