BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2983154 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01643
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE HYPOTUBE HAD BROKEN APPROXIMATELY 200MM DISTAL TO THE CATHETER'S STRAIN RELIEF. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. SEVERAL KINKS WERE IDENTIFIED ALONG THE HYPOTUBE. ANOTHER KINK WAS IN THE TIP SECTION OF THE DEVICE AT 4MM PROXIMAL TO THE EXIT PORT. THE TIP OF THE DEVICE WAS DAMAGED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE TIP BEING PUSHED UP AGAINST A RESTRICTION, DURING ATTEMPTS TO CROSS THE LESION. THE CRIMPED STENT AND BALLOON OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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 MDR#2134265-2013-01630 AND 2134265-2013-01077. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A CATHETER SHAFT FRACTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.5 X 24MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS INTRODUCED AND WHILE THE DEVICE WAS BEING ADVANCED TO THE TARGET LESION, A SHAFT FRACTURE OCCURRED. THE DEVICE WAS REMOVED AND ANOTHER 2.5 X 24MM PROMUS ELEMENT STENT WAS IMPLANTED. THE 2.5 X 20MM PROMUS ELEMENT SDS WAS THEN INTRODUCED WITH TWO UNSPECIFIED GUIDE WIRES. THE 2.5 X 20MM STENT CAUGHT ON THE IMPLANTED STENT AND BECOME DEFORMED AND DISLODGED. BOTH THE DISLODGED 2.5 X 20MM STENT AND THE IMPLANTED 2.5 X 24MM STENT WERE REMOVED FROM THE PATIENT, ALONG WITH THE GUIDE WIRES. AN UNSPECIFIED PROMUS ELEMENT STENT WAS IMPLANTED IN THE TARGET LESION TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE SHAFT FRACTURE OCCURRED AT THE PROXIMAL END OF THE DEVICE OUTSIDE THE PATIENT AND THAT THE DEVICE WAS RETRIEVED BY HAND WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87768 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324250 0015381627

    Patients

    Seq Age Sex Outcome Treatment
    1