BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3193345 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04488
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 31, 2013
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4). 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 PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE, STENT DAMAGE POST DEPLOYMENT OCCURRED. THE PATIENT ARRIVED AT CATHLAB IN ACUTE CORONARY SYNDROME AND AT THE FIRST ANGIOGRAPHY HE PRESENTED A CRITICAL STENOSIS. ACCESS WAS OBTAINED VIA RADIAL ARTERY. THE UNSPECIFIED STENOSED TARGET LESION WAS A DE NOVO AND ECCENTRIC LESION LOCATED IN THE MILDLY CALCIFIED AND SEVERELY TORTUOUS PROXIMAL SEGMENT OF THE LEFT ANTERIOR DESCENDING ARTERY WITH A LESION LENGTH OF 50MM AND A VESSEL DIAMETER OF 4MM. AN UNSPECIFIED PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM WAS IMPLANTED INTO THE TARGET VESSEL. THE PHYSICIAN THEN POST DILATED THE PROXIMAL PART OF THE STENT WITH A NON COMPLIANT BALLOON AND AFTER WHICH THE PHYSICIAN NOTICED AT THE ANGIO A CLEAR IMAGE WITH A SIGNIFICANT CHANGE OF THE STENT LENGTH. AFTER THAT, HE TRIED TO DILATE AGAIN THE DEFORMED PROXIMAL EDGE OF THE STENT, USING MANY BALLOONS OF DIFFERENT DIAMETERS, HE WAS NOT ABLE TO CROSS THE STENT WITH A BIG BALLOON AND HE HAD TO START WITH A 1.25 SEMI COMPLIANT BALLOON. AT THE END, THERE WAS A GOOD ANGIOGRAPHIC RESULT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292032 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK634

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDEWIRE: BMW 0,014"1| GUIDE CATHETER: 7 F GC