BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3193182 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04376
    Event Type
    Death
    Date Received
    June 27, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). T 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 PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE, AS STENT "APPEARED FRACTURED" AND SUBSEQUENT TO THE PROCEDURE THE PATIENT DIED. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS PROXIMAL CIRCUMFLEX (CX) ARTERY. IN (B)(6) 2012, AN UNSPECIFIED STENT HAD BEEN IMPLANTED IN THE CX. THE PATIENT WAS VERY SICK AND PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION (AMI). DURING THE CATHETERIZATION, THE DECISION WAS MADE TO PLACE ANOTHER STENT PROXIMAL TO THE STENT IMPLANTED IN (B)(6) 2012. A 3.00 MM X 8 MM PROMUS ELEMENT PLUS STENT WAS SELECTED AND PLACED PROXIMAL TO THE PREVIOUSLY IMPLANTED STENT. THE LESION WAS THEN POST-DILATED WITH A 3.25 X 8 NC QUANTUM. THE PHYSICIAN COMMENTED DURING THE CASE THAT THE JUST PLACED STENT "APPEARED TO BE FRACTURED". IT WAS NOTED WHAT APPEARS TO BE THE "OPEN CELL DESIGN OF THE PE+ AROUND AN AREA OF CALCIFIED PLAQUE". THE CASE WAS SUCCESSFULLY COMPLETED. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. TWO DAYS LATER, THE PATIENT PASSED AWAY IN THE HOSPITAL. THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294416 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911408300 16044865

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death