BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 4110146 · Received September 23, 2014

    Report

    Report Number
    2134265-2014-05651
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 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

    DEVICE EVALUATED BY MFR: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND THE DISTAL PORTION OF THE CRIMPED STENT WAS STRETCHED DISTALLY OVER THE DISTAL MARKERBAND. THE PROXIMAL PORTION OF THE CRIMPED STENT WERE DEFORMED, DISTORTED AND LIFTED UPWARDS FROM THE STENT PROFILE. THIS TYPE OF DAMAGE IS CONSISTENT WITH RESISTANCE BEING ENCOUNTERED WHILE ATTEMPTING TO ADVANCE THE DEVICE. THE BUMPER TIP OF THE DEVICE SHOWED SIGNS OF DAMAGE TO THE DISTAL EDGE OF THE TIP. THIS TYPE OF DAMAGE IS CONSISTENT WITH RESISTANCE BEING ENCOUNTERED ON ADVANCEMENT OF THE STENT DELIVERY CATHETER. 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 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. 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 16MM X 2.25MM PROMUS PREMIER¿ STENT WAS ADVANCED TO THE LESION BUT ENCOUNTERED DIFFICULTY DUE TO STRONG RESISTANCE. THE PHYSICIAN REMOVED THE DEVICE TO USE A NON BSC GUIDE CATHETER EXTENSION HOWEVER IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS FLARED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 16MM X 2.25MM PROMUS PREMIER¿ STENT WAS ADVANCED TO THE LESION BUT ENCOUNTERED DIFFICULTY DUE TO STRONG RESISTANCE. THE PHYSICIAN REMOVED THE DEVICE TO USE A NON BSC GUIDE CATHETER EXTENSION HOWEVER IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS FLARED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590773 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925116220 16863997

    Patients

    Seq Age Sex Outcome Treatment
    1