BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 4143340 · Received October 6, 2014

    Report

    Report Number
    2134265-2014-05947
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. THE STENT HAD DETACHED FROM THE BALLOON AND WAS RETURNED FOR ANALYSIS. THE ENTIRE LENGTH OF THE STENT WAS DAMAGED WITH THE STENT STRUTS DEFORMED, DISTORTED AND STRETCHED. 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. CRIMP MARKINGS WERE EVIDENT ON THE ENTIRE LENGTH OF THE BALLOON WALL INDICATING OVERALL CRIMP CONTACT BETWEEN THE COATED STENT AND BALLOON. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ON HYPOTUBE. THE STENT CRIMP FORCE, THE CRIMP TEMPERATURE AND THE CRIMP DURATION FOR THE DEVICE ALL ARE WITHIN THE SPECIFIED RANGE. REVIEWING THESE SPECIFIED PARAMETERS AGAINST THE BATCH RECORDS FOR THE CRIMPED UNIT, THERE ARE NO ANOMALIES EVIDENT. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE SHAFT PROFILE. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED SAPHENOUS VEIN GRAFT (SVG). A 3.00X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT WAS ELONGATED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. OUTSIDE OF THE PATIENT, THE TECH PULLED THE DEFORMED STENT OFF THE STENT DELIVERY BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED SAPHENOUS VEIN GRAFT (SVG). A 3.00X38MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT WAS ELONGATED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. OUTSIDE OF THE PATIENT, THE TECH PULLED THE DEFORMED STENT OFF THE STENT DELIVERY BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623365 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952838300 17010392

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR