BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 3883436 · Received June 19, 2014

    Report

    Report Number
    2134265-2014-03497
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 23, 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 EVALUATION 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

    SAME CASE AS MDR ID# 2134265-2014-03496. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN A TORTUOUS AND HIGHLY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 2.25X12MM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE PROXIMAL AND MID RCA INFLATED TO 8ATM FOR 15 SECONDS THEN AGAIN AT 7ATM FOR 10 SECONDS. A 2.75X38MM PROMUS PREMIER STENT WAS THEN DEPLOYED IN THE RCA AT 13ATM FOR 20 SECONDS. ADDITIONALLY A 3.0X12MM PROMUS PREMIER STENT WAS DEPLOYED IN THE PROX RCA AT 13ATM FOR 17 SECONDS. ACTIVATED CLOTTING TIME WAS DRAWN AND RESULTS WERE 407 SECONDS. THE THROMBOSIS WAS TREATED WITH BALLOON ANGIOPLASTY OF RCA WITH A 3.0X20MM NC QUANTUM APEX BALLOON. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND NO FURTHER PATIENT COMPLICATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361475 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952812300

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention