BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3000388 · Received March 12, 2013

    Report

    Report Number
    2134265-2013-01422
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. 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 DEFORMATION AND STENT MIGRATION OCCURRED. THE PROCEDURE TREATED THE 95% STENOSED TARGET LESION LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS SAPHENOUS VEIN GRAFT (SVG) GOING TO THE LEFT ANTERIOR DESCENDING ARTERY. A 4.0X16MM PROMUS ELEMENT PLUS STENT WAS DEPLOYED AT 16 ATMS IN THE PROXIMAL PORTION OF THE SVG JUST OUTSIDE OF THE GUIDE CATHETER. THE STENT WAS WELL EXPANDED AND WELL APPOSED. NEXT A NON-BSC GUIDE CATHETER DEEP SEATED DUE TO TENSION ON THE GUIDE WIRE AND MADE CONTACT WITH THE 4.0X16MM PROMUS ELEMENT PLUS STENT LIKELY CAUSING STENT DEFORMATION. THEN WHEN TRYING TO PASS A 4.0X28MM PROMUS ELEMENT PLUS STENT, THE STRUT FROM THE 4.0X16MM PROMUS ELEMENT PLUS WAS CAUGHT CAUSING THE 4.0X16MM PROMUS ELEMENT PLUS STENT TO MIGRATE ABOUT 5CM AND COMPRESS MOSTLY ON THE PROXIMAL EDGE. POST DILATION WAS PERFORMED ON THE 4.0X16MM PROMUS ELEMENT PLUS STENT AND THE FINAL CONDITION OF THE STENT WAS CONSIDERED WELL EXPANDED AND WELL APPOSED. NO FURTHER PATIENT COMPLICATIONS OCCURRED AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103038 PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK717

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention CORDIS GUIDE CATHETER| FILTERWIRE EZ| 4.0X28MM PROMUS ELEMENT PLUS STENT