BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS PREMIER¿

    MDR report key: 6132046 · Received November 29, 2016

    Report

    Report Number
    2134265-2016-10647
    Event Type
    Death
    Date Received
    November 29, 2016
    Date of Event
    October 29, 2016
    Report Date
    November 4, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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

    SAME CASE AS MDR ID: 2134265-2016-10646, 2134265-2016-10648. IT WAS REPORTED THAT NO FLOW OCCURRED AND THE PATIENT DIED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50X20MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. THE PHYSICIAN DECIDED TO PLACE ANOTHER STENT. A 2.50X8MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS DEPLOYED PROXIMAL TO THE 2.50X20MM PROMUS PREMIER¿ STENT. THE 2.50X8MM STENT WAS THEN INFLATED AND AN IMAGE WAS TAKEN. HOWEVER, THE WHOLE VESSEL SHUT DOWN. ANOTHER 2.50X8MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED BUT THE VESSEL WAS STILL SHUT DOWN. MULTIPLE BALLOON CATHETERS WERE ADVANCED TO INFLATE THE IMPLANTED STENTS BUT IT DID NOT WORK. HEMODYNAMICALLY, THE PATIENT STARTED CRASHING. THE PHYSICIAN PERFORMED CARDIOPULMONARY RESUSCITATION (CPR) ON THE PATIENT. WHILE DOING THE CPR, THE WIRE CAME OUT FROM THE PATIENT AND THE PHYSICIAN COULD NOT GET THE WIRE BACK IN THE VESSEL. SUBSEQUENTLY, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782150 PROMUS PREMIER¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952808250

    Patients

    Seq Age Sex Outcome Treatment
    1 Death