BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3232580 · Received July 18, 2013

    Report

    Report Number
    2134265-2013-04861
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. IF IMPLANTED, GIVE DATE: SEVERAL MONTHS PRIOR EVENT. 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 SUBSEQUENT TO A PERCUTANEOUS CORONARY INTERVENTION, IN-STENT RESTENOSIS AND ANGINA OCCURRED. THE TARGET LESION WAS LOCATED IN THE OSTIAL CIRCUMFLEX ARTERY. THE PHYSICIAN TREATED THE LESION WITH PLACEMENT OF A 2.5MM X 20MM PROMUS ELEMENT PLUS STENT. SEVERAL MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED DUE TO ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. AN IN-STENT RESTENOSIS WAS NOTED AT THE OSTIUM OF THE PREVIOUSLY IMPLANTED STENT. THE PHYSICIAN TREATED THE LESION WITH BALLOON ANGIOPLASTY USING AN UNSPECIFIED CUTTING BALLOON, A NON-BSC BALLOON AND ONE NON-BSC IMAGING CATHETER. ADDITIONAL STENTING WITH A NON-BSC STENT WAS MADE TO RESOLVE THE VESSEL DISSECTION THAT OCCURRED IN THE LEFT MAIN CORONARY ARTERY. THE PROCEDURE WAS THEN COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334351 PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK717

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention