BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 3883887 · Received June 19, 2014

    Report

    Report Number
    2134265-2014-03580
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 24, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS 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

    IT WAS REPORTED THAT THROMBOSIS OCCURRED. PATIENT ARRIVED IN STEMI STATUS. HEPARIN WAS ADMINISTERED. A 2.5 X 24 PROMUS PREMIER STENT WAS DEPLOYED AT 18ATM FOR 30 SECONDS IN THE RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS ADMINISTERED EFFIENT IN THE CATH LAB AND TRANSFERRED TO HOSPITAL ROOM. THE PATIENT VOMITED. ABOUT 3 HOURS LATER THE PATIENT COMPLAINED OF CHEST PAIN AND HAD ST CHANGES AND WAS TAKEN BACK TO CATH LAB IN STEMI STATUS. IT WAS FOUND THE RCA WAS CLOTTED OFF. A 2.5X12MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED IN THE RCA AND INFLATED 4 TIMES TO 12-16ATM FOR 18- 60 SECONDS. MEDICATIONS RECEIVED INCLUDED HEPARIN, ANGIOMAX AND INTEGRILIN. PATIENT DOING FINE AND WAS DISCHARGED A 'COUPLE' OF DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360587 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952824250

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention