BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 6186054 · Received December 19, 2016

    Report

    Report Number
    2024168-2016-09005
    Event Type
    Death
    Date Received
    December 19, 2016
    Date of Event
    November 10, 2016
    Report Date
    December 19, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    UDI-DI
    08717648156199
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE DEVICE WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED PATIENT EFFECTS. BASED ON THE INFORMATION REVIEWED, THE REPORTED PATIENT EFFECT OF DEATH WAS A RESULT OF THE HEART AND RESPIRATORY FAILURE; HOWEVER, A CAUSE FOR HEART/RESPIRATORY FAILURE AND RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED. THE REPORTED HOSPITALIZATION WAS A RESULT OF CASE SPECIFIC CIRCUMSTANCES. THIS EVENT WAS FURTHER REVIEWED BY AN ABBOTT VASCULAR SENIOR MEDICAL ADVISOR. THE REVIEWER NOTED THAT THE DEATH WAS REPORTED 3 YEARS AFTER A SUCCESSFUL PROCEDURE IN A CONTEXT OF RESPIRATORY AND CIRCULATORY FAILURE FOLLOWING URINARY TRACT INFECTION; THERE IS NO EVIDENCE OF DEVICE RELATIONSHIP AND DEATH WAS MOST LIKELY DUE TO COMORBIDITIES. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF WORSENING HEART FAILURE, RESPIRATORY FAILURE, AND DEATH, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    THIS REPORT IS CONSERVATIVELY FILED FOR PATIENT DEATH DUE TO RESPIRATORY AND CONGESTIVE HEART FAILURE. IT WAS REPORTED THAT ON (B)(6) 2013, ONE MITRACLIP WAS IMPLANTED IN A PATIENT WITH MIXED FUNCTIONAL AND DEGENERATIVE MITRAL REGURGITATION (MR), REDUCING THE MR FROM 4+ TO 2+, WITHOUT A REPORTED DEVICE MALFUNCTION. IN (B)(6) 2016, THE PATIENT WAS HOSPITALIZED DUE TO A URINARY TRACT INFECTION (UTI). PER PHYSICIAN, THE UTI REQUIRING HOSPITALIZATION WAS UNRELATED TO THE DEVICE AND UNRELATED TO THE CLIP PROCEDURE. ON (B)(6) 2016, TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED THE EXPECTED DOUBLE ORIFICE MORPHOLOGY, INDICATING PROPER CLIP PLACEMENT ON THE MITRAL VALVE LEAFLETS. ON (B)(6) 2016, THE PATIENT EXPERIENCED A STOMACHACHE AND WAS TAKEN TO THE EMERGENCY ROOM. THE PATIENT WAS THEN HOSPITALIZED. ON (B)(6) 2016, THE PATIENT EXPIRED DUE TO RESPIRATORY FAILURE AND CONGESTIVE HEART FAILURE. PER THE STUDY PHYSICIAN, THE DEVICE RELATIONSHIP TO THE DEATH WAS NOT ASSESSABLE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838013 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 1021540519 08717648156199

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death