BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3122317 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03277
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT ALMOST THE ENTIRE STENT WAS STRETCHED DISTALLY OUT OVER THE TIP OF THE STENT DELIVERY SYSTEM. APPROXIMATELY 5MM OF THE STENTS PROFILE REMAINED UNDAMAGED AND CRIMPED TO THE BALLOON AT THE PROXIMAL EDGE. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS CAUSED BY ANOTHER DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE STENT MOVED ON THE BALLOON AND REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE BIFURCATION OF THE PROXIMAL OBTUSE MARGINAL AND THE CIRCUMFLEX ARTERIES. A 3.00X16MM PROMUS PREMIER STENT WAS ADVANCED AND DEPLOYED IN THE PROXIMAL OBTUSE MARGINAL AND EXTENDING INTO THE PROXIMAL CIRCUMFLEX ARTERY. A 2.00MM UNSPECIFIED BALLOON CATHETER WAS THEN ADVANCED THROUGH THE STRUTS OF THE 3.00X16MM PROMUS PREMIER STENT AND USED TO DILATE AN OPENING BETWEEN THE STRUTS. A 3.00X28MM PROMUS PREMIER STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED THROUGH THE STRUTS OF THE 3.00X16MM PROMUS PREMIER STENT WITH THE INTENT OF DEPLOYING IT IN THE "KISSING" FASHION IN THE DISTAL CIRCUMFLEX ARTERY. HOWEVER, THE 3.00X28MM PROMUS PREMIER SDS COULD NOT PASS THROUGH THE DEPLOYED STENT STRUTS AND UPON WITHDRAWAL IT BECAME STUCK WITHIN THE DEPLOYED STENT STRUTS. SOME FORCE WAS APPLIED TO REMOVED THE 3.00X28MM PROMUS PREMIER SDS AND THE STENT MOVED ON THE BALLOON BUT DID NOT DISLODGE ENTIRELY. THE 3.00X28MM PROMUS PREMIER SDS WAS ABLE TO BE REMOVED INTACT. THE 3.00X16MM PROMUS PREMIER STENT WAS VIEWED ON X-RAY AND REMAINED WELL POSITIONED AND WELL APPOSED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT MOVED ON THE BALLOON AND REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE BIFURCATION OF THE PROXIMAL OBTUSE MARGINAL AND THE CIRCUMFLEX ARTERIES. A 3.00X16MM PROMUS PREMIER STENT WAS ADVANCED AND DEPLOYED IN THE PROXIMAL OBTUSE MARGINAL AND EXTENDING INTO THE PROXIMAL CIRCUMFLEX ARTERY. A 2.00MM UNSPECIFIED BALLOON CATHETER WAS THEN ADVANCED THROUGH THE STRUTS OF THE 3.00X16MM PROMUS PREMIER STENT AND USED TO DILATE AN OPENING BETWEEN THE STRUTS. A 3.00X28MM PROMUS PREMIER STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED THROUGH THE STRUTS OF THE 3.00X16MM PROMUS PREMIER STENT WITH THE INTENT OF DEPLOYING IT IN THE "KISSING" FASHION IN THE DISTAL CIRCUMFLEX ARTERY. HOWEVER, THE 3.00X28MM PROMUS PREMIER SDS COULD NOT PASS THROUGH THE DEPLOYED STENT STRUTS AND UPON WITHDRAWAL IT BECAME STUCK WITHIN THE DEPLOYED STENT STRUTS. SOME FORCE WAS APPLIED TO REMOVED THE 3.00X28MM PROMUS PREMIER SDS AND THE STENT MOVED ON THE BALLOON BUT DID NOT DISLODGE ENTIRELY. THE 3.00X28MM PROMUS PREMIER SDS WAS ABLE TO BE REMOVED INTACT. THE 3.00X16MM PROMUS PREMIER STENT WAS VIEWED ON X-RAY AND REMAINED WELL POSITIONED AND WELL APPOSED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224250 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925128300 15832233

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR