BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1726849 · Received June 17, 2010

    Report

    Report Number
    2134265-2010-02623
    Event Type
    Death
    Date Received
    June 17, 2010
    Date of Event
    May 22, 2010
    Report Date
    May 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE A STENT DISLODGEMENT OCCURRED AND THE PATIENT EXPIRED. THE PATIENT PRESENTED TO THE HOSPITAL WITH ACUTE CORONARY SYNDROME IN CARDIOGENIC SHOCK WITH A BLOOD PRESSURE OF 60 MMHG. A PROMUS ELEMENT STENT OF UNKNOWN SIZE WAS SUCCESSFULLY IMPLANTED IN THE 99% STENOSED UNPROTECTED LEFT MAIN (LM). AFTER DEPLOYMENT OF THE STENT THE FLOW OF BLOOD THROUGH THE LM WAS RESTORED; HOWEVER, THE PATIENT STILL REMAINED UNSTABLE AND THE PATIENT WAS SHOCKED WITH A DEFIBRILLATOR. A 2.0MM MAVERICK BALLOON ALONG WITH A 3.0MM MAVERICK BALLOON WERE THEN USED TO PREDILATE THE 95% STENOSED, MODERATELY TORTUOUS AND CALCIFIED, 4.5X10MM RIGHT CORONARY ARTERY (RCA). A 4.0X16MM PROMUS ELEMENT STENT WAS THEN ADVANCED TO THE RCA. DURING ADVANCEMENT TO THE LESION THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS) IN THE OSTIUM OF THE RCA BECAUSE THE PATIENT HAD ¿VELLICATED¿. THE STENT WAS SNARED BACK TO THE INTENDED LESION AND THE SDS BALLOON WAS RE-ADVANCED INTO THE DISLODGED STENT. WHILE THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE STENT WITH THE SDS BALLOON THE PATIENT EXPERIENCED A LARGE MYOCARDIAL INFARCTION IN THE LM. THE PATIENT EXPIRED PRIOR TO THE STENT BEING DEPLOYED. THE PHYSICIAN DID NOT BELIEVE THAT THE PATIENT¿S DEATH WAS RELATED TO THE PROMUS ELEMENT STENTS THAT WERE IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316400 0013333946

    Patients

    Seq Age Sex Outcome Treatment
    1 Death PROMUS ELEMENT STENT| BMW GUIDE WIRE| LAUNCHER 6F JR4 GUIDE CATHETER