BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2111724 · Received June 2, 2011

    Report

    Report Number
    2134265-2011-01937
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED, MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD). WITHOUT PREDILATING, A 3.0X16MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS DEPLOYED AT 14ATM/10SEC. THE STENT WAS UNDER EXPANDED AND IT WAS POST DILATED WITH A 3.0X16MM QUANTUM MAVERICK BALLOON INFLATED TO 24ATM FOR 10 SECONDS. IT WAS NOTED THAT THE STENT WAS CONCERTINED. NEXT, AN ATLANTIS PRO IMAGING CATHETER WAS ADVANCED AND WAS SEVERELY TRAPPED IN THE SHORTENED STENT. IN ORDER TO REMOVE THE CATHETER, THE PHYSICIAN HAD TO PUSH AND PULL. THEN A NON-BSC STENT WAS PLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316300 0014239038

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention ATLANTIS PRO IMAGING CATHETER| 3.0X16MM QUANTUM MAVERICK BALLOON