BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3912352 · Received July 3, 2014

    Report

    Report Number
    2134265-2014-03798
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: HYPOTUBE PROFILE: A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKING ON THE HYPOTUBE SHAFT AND THE SHAFT ITSELF WAS BROKEN AT TWO LOCATIONS IN THE REGION OF THE SEVERE KINKING. THE FIRST HYPOTUBE BREAK OCCURRED 184MM DISTAL FROM THE STRAIN RELIEF WHILE THE SECOND BREAK OCCURRED 202MM. VISUAL EXAMINATION OF THE BUMPER TIP FOUND NO DAMAGE OR ISSUES WITH ITS PROFILE. THE BALLOON CONES 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 EXAMINATION OF THE STENT FOUND NO ISSUES WITH ITS PROFILE. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MIDSHAFT SECTION FOUND NO ISSUES WITH THEIR PROFILE. 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 ID 2134265-2014-03797 AND MDR ID 2134265-2014-03796. IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND "HEAVILY" CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH A 2.5MM X 12MM UNSPECIFIED BALLOON CATHETER AND A 2.5MM X 28MM PROMUS PREMIER¿ STENT WAS SUCCESSFULLY IMPLANTED IN THE MID LAD. IT WAS DETERMINED THAT ANOTHER STENT HAS TO BE PLACED PROXIMAL THE FIRST STENT. SO A 3.50MM X 20MM PROMUS PREMIER¿ STENT WAS ADVANCED TO THE LESION BUT FAILED AFTER SEVERAL ATTEMPTS. IT WAS THEN NOTED THAT THE PROXIMAL PORTION OF THE SHAFT OF THE STENT DELIVERY SYSTEM (SDS) WAS FRACTURED. THE 3.50MM X 20MM PROMUS PREMIER¿ STENT WAS REMOVED FROM THE PATIENT SUCCESSFULLY. THEN ANOTHER 3.50MM X 20MM PROMUS PREMIER¿ STENT WAS ADVANCED TO THE LESION BUT ENCOUNTERED DIFFICULTY. IT WAS ALSO NOTED THAT THE PROXIMAL SHAFT OF THE SDS WAS FRACTURED. THE 3.50MM X 20MM PROMUS PREMIER¿ STENT WAS REMOVED SUCCESSFULLY FROM THE PATIENT. ANOTHER 3.0MM X 18MM NON BSC STENT WAS ADVANCED TO THE LESION BUT THE DEVICE MET RESISTANCE AND THE PROXIMAL SHAFT OF THE DEVICE WAS ALSO FRACTURED. A 3.00MM X 16MM PROMUS PREMIER¿ STENT WAS ALSO ADVANCED TO THE LESION BUT RESISTANCE WAS ENCOUNTERED AND THE PROXIMAL SHAFT OF THE SDS WAS FRACTURED. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE LESION WAS THEN DILATED USING A 3.0MM X 15MM NON COMPLIANT BALLOON CATHETER. A 3.0MM X 20MM PROMUS PREMIER¿ STENT WAS ADVANCED AND IMPLANTED IN THE LESION SUCCESSFULLY THEN A 3.25MM X 20MM APEX BALLOON CATHETER WAS USED FOR POST DILATION AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS DOING WELL AND WAS DISCHARGED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2014-03797 AND MDR ID 2134265-2014-03796. IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND "HEAVILY" CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH A 2.5MM X 12MM UNSPECIFIED BALLOON CATHETER AND A 2.5MM X 28MM PROMUS PREMIER STENT WAS SUCCESSFULLY IMPLANTED IN THE MID LAD. IT WAS DETERMINED THAT ANOTHER STENT HAS TO BE PLACED PROXIMAL THE FIRST STENT. SO A 3.50MM X 20MM PROMUS PREMIER STENT WAS ADVANCED TO THE LESION BUT FAILED AFTER SEVERAL ATTEMPTS. IT WAS THEN NOTED THAT THE PROXIMAL PORTION OF THE SHAFT OF THE STENT DELIVERY SYSTEM (SDS) WAS FRACTURED. THE 3.50MM X 20MM PROMUS PREMIER STENT WAS REMOVED FROM THE PATIENT SUCCESSFULLY. THEN ANOTHER 3.50MM X 20MM PROMUS PREMIER STENT WAS ADVANCED TO THE LESION BUT ENCOUNTERED DIFFICULTY. IT WAS ALSO NOTED THAT THE PROXIMAL SHAFT OF THE SDS WAS FRACTURED. THE 3.50MM X 20MM PROMUS PREMIER STENT WAS REMOVED SUCCESSFULLY FROM THE PATIENT. ANOTHER 3.0MM X 18MM NON BSC STENT WAS ADVANCED TO THE LESION BUT THE DEVICE MET RESISTANCE AND THE PROXIMAL SHAFT OF THE DEVICE WAS ALSO FRACTURED. A 3.00MM X 16MM PROMUS PREMIER STENT WAS ALSO ADVANCED TO THE LESION BUT RESISTANCE WAS ENCOUNTERED AND THE PROXIMAL SHAFT OF THE SDS WAS FRACTURED. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE LESION WAS THEN DILATED USING A 3.0MM X 15MM NON COMPLIANT BALLOON CATHETER. A 3.0MM X 20MM PROMUS PREMIER STENT WAS ADVANCED AND IMPLANTED IN THE LESION SUCCESSFULLY THEN A 3.25MM X 20MM APEX BALLOON CATHETER WAS USED FOR POST DILATION AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS DOING WELL AND WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391450 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952816300 16767683

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR