BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2833370 · Received November 15, 2012

    Report

    Report Number
    2134265-2012-06878
    Event Type
    Death
    Date Received
    November 15, 2012
    Date of Event
    October 20, 2012
    Report Date
    October 20, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2012-06879 AND 2134265-2012-06880. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A VESSEL RUPTURE OCCURRED AND FOLLOWING THE PROCEDURE THE PATIENT EXPIRED. THE 80% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL TO DISTAL RIGHT CORONARY ARTERY (RCA). A 3.00X16MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE DISTAL RCA AND DEPLOYED. A 3.50X32MM PROMUS ELEMENT SDS WAS THEN ADVANCED TO THE MID RCA WITH THE INTENTION OF DEPLOYING IT OVERLAPPING THE 3.00X16MM PROMUS ELEMENT STENT. HOWEVER, THE 3.50X32MM PROMUS ELEMENT SDS WAS UNABLE TO CROSS THE LESION DUE TO THE CALCIFICATION. DILATION WITH AN UNSPECIFIED BALLOON CATHETER WAS PERFORMED (SEVERAL BALLOON CATHETERS WERE USED DURING THE PROCEDURE). THE SAME 3.50X32MM PROMUS ELEMENT SDS WAS ADVANCED TO THE MID RCA WHEN A VESSEL RUPTURE WAS NOTED. AN UNSPECIFIED BALLOON CATHETER WAS ADVANCED AND INFLATED TO TREAT THE RUPTURE. THE PATIENT'S CONDITION RETURNED TO STABLE AND THE PROCEDURE WAS COMPLETED WITH THE DEPLOYMENT OF THE 3.50X32MM PROMUS ELEMENT STENT AND A 3.50X24MM PROMUS ELEMENT STENT FROM THE MID TO PROXIMAL RCA. THE PROCEDURE WAS CONSIDERED COMPLETED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, THE PATIENT EXPIRED LATER THAT DAY. THE CAUSE OF DEATH IS UNKNOWN. IT IS THE OPINION OF THE PHYSICIAN THAT THE PROMUS ELEMENT STENT DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316300 15415479

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death