BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 6058802 · Received October 26, 2016

    Report

    Report Number
    2024168-2016-07325
    Event Type
    Death
    Date Received
    October 26, 2016
    Date of Event
    October 1, 2016
    Report Date
    November 9, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CLIP REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. THE REPORTED PATIENT EFFECTS OF WORSENING MITRAL REGURGITATION (MR), HEART FAILURE, MITRAL VALVE INJURY (TISSUE DAMAGE) AND DEATH, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THIS EVENT WAS FURTHER REVIEWED BY AN ABBOTT VASCULAR SENIOR MEDICAL ADVISOR. THE REVIEWER NOTED THAT THE PATIENT HAD VERY CHALLENGING ANATOMY DUE TO EHLARS-DANLOS SYNDROME WHICH MAY HAVE MADE DEVICE STABILITY IMPOSSIBLE DUE TO FRIABLE TISSUE. THE PATIENT DEATH WAS RELATED TO HEART FAILURE, POSSIBLY TRIGGERED BY RECURRENT MR AND THE DEVICE WAS NOT DIRECTLY CAUSAL FOR DEATH. BASED ON THE INFORMATION REVIEWED, THE REPORTED PATIENT EFFECTS OF TISSUE DAMAGE, WORSENING MR AND HEART FAILURE APPEAR TO BE RELATED TO PATIENT MORPHOLOGY/PATHOLOGY (CO-MORBIDITIES) AND DUE TO EHLARS-DANLOS SYNDROME. THE REPORTED DEATH APPEARS TO BE A RESULT OF THE HEART FAILURE ND THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THE INCREASE IN MITRAL REGURGITATION, LEAFLET DAMAGE AND DEATH. IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2016 TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. THE PATIENT HAD FRIABLE TISSUE DUE TO EHLARS-DANLOS SYNDROME, MULTIPLE COMORBIDITIES AND WAS NOT A SURGICAL CANDIDATE. THREE CLIPS WERE IMPLANTED, REDUCING THE MR TO 2+. ON (B)(6) 2016, THE PATIENT WAS EXPERIENCING WORSENED SYMPTOMS. ECHOCARDIOGRAM WAS PERFORMED WHICH FOUND THAT THE LEAFLET APPEARED TO BE TORN AND THE MR HAD INCREASED TO 4+. THE CLIPS WERE CONFIRMED TO BE IN STABLE POSITION. THE PATIENT DIED THE SAME DAY DUE TO HEART FAILURE. IN THE PHYSICIANS OPINION, THE FRIABLE TISSUE LIKELY CONTRIBUTED TO THE LEAFLET TEAR; HOWEVER, THERE WAS NO SUSPECTED LINK BETWEEN THE MITRACLIP DEVICE AND THE DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708930 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 60607U246

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death 2 ADDITIONAL MITRACLIPS IMPLANTED