BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 4092469 · Received September 16, 2014

    Report

    Report Number
    2134265-2014-05547
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 MFR: THE STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND THAT THE DISTAL HALF OF THE STENT WAS DAMAGED SO THAT THE STENT WAS STRETCHED OVER THE TIP OF THE DEVICE FOR A DISTANCE OF 6 MM. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE DURING REMOVAL OF THE DEVICE FROM THE PATIENT. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. THE BALLOON CONE PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ALONG THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE SHAFT POLYMER EXTRUSION PROFILE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE CAUSE OF THE REPORTED DIFFICULTIES MAY BE DUE INTERACTION WITH ANOTHER DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT MOVEMENT ON BALLOON OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN NON CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 24MM X 2.50MM PROMUS PREMIER¿ STENT WAS ADVANCED TOWARDS THE FIRST DIAGONAL OF LAD HOWEVER IT CAME IN CONTACT WITH THE 3.5MM X 32MM PROMUS PREMIER¿ STENT IMPLANTED IN THE PROXIMAL LAD. AS A RESULT, THE 24MM X 2.50MM PROMUS PREMIER¿ STENT MOVED ON ITS DELIVERY SYSTEM BALLOON. THERE WAS NO DAMAGE NOTED ON THE STENT IMPLANTED IN THE PROXIMAL LAD. THE DEVICE WAS WITHDRAWN WITHOUT RESISTANCE. THE PROCEDURE WAS COMPLETED USING A 3MM X 24 PROMUS PREMIER¿ STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT MOVEMENT ON BALLOON OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN NON CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 24MM X 2.50MM PROMUS PREMIER¿ STENT WAS ADVANCED TOWARDS THE FIRST DIAGONAL OF LAD HOWEVER IT CAME IN CONTACT WITH THE 3.5MM X 32MM PROMUS PREMIER¿ STENT IMPLANTED IN THE PROXIMAL LAD. AS A RESULT, THE 24MM X 2.50MM PROMUS PREMIER¿ STENT MOVED ON ITS DELIVERY SYSTEM BALLOON. THERE WAS NO DAMAGE NOTED ON THE STENT IMPLANTED IN THE PROXIMAL LAD. THE DEVICE WAS WITHDRAWN WITHOUT RESISTANCE. THE PROCEDURE WAS COMPLETED USING A 3MM X 24 PROMUS PREMIER¿ STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573342 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925124250 16840829

    Patients

    Seq Age Sex Outcome Treatment
    1