BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ? LONG

    MDR report key: 3222587 · Received July 12, 2013

    Report

    Report Number
    2134265-2013-04841
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    May 11, 2013
    Report Date
    June 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE CATHETER WAS RETURNED WITHOUT STENT. A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE TIP WAS SLIGHTLY STRETCHED, KINKED AND FLARED. THE HYPOTUBE WAS SEVERELY KINKED AT VARIOUS LOCATIONS. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE BALLOON AND INFLATION LUMEN WERE PARTLY FILLED WITH CONTRAST MEDIA INDICATING THE DEVICE WAS PREPPED FOR USE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2013-04842. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT RADIAL ARTERY. THE 85% STENOSED TARGET LESION WAS A DE NOVO LESION LOCATED IN THE MODERATELY CALCIFIED AND NON-TORTUOUS RIGHT CORONARY ARTERY (RCA), WITH A DIAMETER OF 3.0MM. AFTER PREDILATION USING AN UNSPECIFIED BALLOON CATHETER, A 2.5MM X 32MM AND 2.5MM X 38MM UNSPECIFIED STENTS WERE IMPLANTED IN THE DISTAL RCA TO THE POSTEROLATERAL BRANCH AND A 3MM X 38MM PROMUS ELEMENT¿ LONG STENT WAS IMPLANTED IN THE PROXIMAL RCA. AN ATTEMPT WAS MADE TO DEPLOY THE 2.75MM X 38MM PROMUS ELEMENT ¿ LONG STENT IN THE MID RCA HOWEVER, THE STENT WAS "TRAPPED" IN THE PREVIOUSLY IMPLANTED 3MM X 38MM PROMUS ELEMENT¿ LONG STENT. AS THE DEVICE WAS PULLED BACK INTO THE GUIDE CATHETER, THE STENT WAS FOUND TO HAVE "CONVERTED INTO A STRAND OF WIRE". BOTH OF THE STENTS ALONG WITH THE GUIDE CATHETER AND THE GUIDE WIRE WAS PULLED OUT AND THE PROCEDURE WAS THEN COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2013-04842. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT RADIAL ARTERY. THE 85% STENOSED TARGET LESION WAS A DE NOVO LESION LOCATED IN THE MODERATELY CALCIFIED AND NON-TORTUOUS RIGHT CORONARY ARTERY (RCA), WITH A DIAMETER OF 3.0MM. AFTER PREDILATION USING AN UNSPECIFIED BALLOON CATHETER, A 2.5MM X 32MM AND 2.5MM X 38MM UNSPECIFIED STENTS WERE IMPLANTED IN THE DISTAL RCA TO THE POSTEROLATERAL BRANCH AND A 3MM X 38MM PROMUS ELEMENT LONG STENT WAS IMPLANTED IN THE PROXIMAL RCA. AN ATTEMPT WAS MADE TO DEPLOY THE 2.75MM X 38MM PROMUS ELEMENT LONG STENT IN THE MID RCA HOWEVER, THE STENT WAS "TRAPPED" IN THE PREVIOUSLY IMPLANTED 3MM X 38MM PROMUS ELEMENT LONG STENT. AS THE DEVICE WAS PULLED BACK INTO THE GUIDE CATHETER, THE STENT WAS FOUND TO HAVE "CONVERTED INTO A STRAND OF WIRE". BOTH OF THE STENTS ALONG WITH THE GUIDE CATHETER AND THE GUIDE WIRE WAS PULLED OUT AND THE PROCEDURE WAS THEN COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322722 PROMUS ELEMENT ? LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338270 15821013

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 3.00X38MM PROMUS ELEMENT STENT