BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 8809083 · Received July 19, 2019

    Report

    Report Number
    2024168-2019-05565
    Event Type
    Death
    Date Received
    July 19, 2019
    Date of Event
    March 22, 2019
    Report Date
    August 20, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICES WERE NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED AS THE PART AND LOT INFORMATION REGARDING THE COMPLAINT DEVICES WAS NOT PROVIDED. THE REPORTED ADVERSE EVENT/PATIENT EFFECT OF DEATH, MITRAL REGURGITATION (MR), THROMBUS (EMBOLI) AND CARDIOGENIC SHOCK LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE CAUSE FOR THE REPORTED DEATH, MITRAL REGURGITATION (MR), THROMBOSIS, CARDIOGENIC SHOCK COULD NOT BE DETERMINED IN THIS INCIDENT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 0

    PATIENT CODES: 1964 LABELED 2262 LABELED 2100 LABELED DEVICE CODES: 2993 LABELED NA INTERNAL FILE NUMBER - (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ARTICLE TITLED: EDGE-TO-EDGE MITRAL VALVE REPAIR WITH EXTENDED CLIP ARMS, EARLY EXPERIENCE FROM A MULTICENTER OBSERVATIONAL STUDY. THE CLIP REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. B3. DATE OF EVENT ESTIMATED D6. IMPLANT DATE ESTIMATED G9: EXEMPTION NUMBER E2019001 PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD.

    Description of Event or Problem · 0

    THIS IS BEING FILED TO REPORT POST PROCEDURE, PATIENT DEATH OCCURRED AFTER INCREASED MITRAL REGURGITATION, CARDIOGENIC SHOCK DUE TO THROMBOSIS. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN IN-HOSPITAL PATIENT DEATH IN A AN (B)(6) YEAR-OLD PATIENT TREATED EMERGENTLY FOR SEVERE SECONDARY MR FOLLOWING CARDIOGENIC SHOCK CAUSED BY THROMBOTIC LEFT MAIN CORONARY ARTERY OCCLUSION THAT HAD BEEN SUCCESSFULLY MANAGED USING PRIMARY PERCUTANEOUS CORONARY INTERVENTION. ADDITIONAL SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE TITLED, EDGE-TO-EDGE MITRAL VALVE REPAIR WITH EXTENDED CLIP ARMS, EARLY EXPERIENCE FROM A MULTICENTER OBSERVATIONAL STUDY". NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599991 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death