BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3983297 · Received August 6, 2014

    Report

    Report Number
    2134265-2014-04885
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    May 8, 2014
    Report Date
    July 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE CRIMPED STENT WAS DETACHED FROM THE BALLOON AND NOT RETURNED WITH DEVICE FOR ANALYSIS. THE BALLOON WAS FOUND TO HAVE THE STENT IMPRESSIONS ON IT AND PILLOWING OF THE BALLOON INDICATING THAT THE STENT WAS CRIMPED PER PROCESS IN THE CORRECT LOCATION DURING MANUFACTURING. IT WAS ALSO NOTED THE STENT OF THE DEVICE HAD BEEN DEPLOYED. THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ON HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. NO ISSUES WERE NOTED WITH THE TIP OF THE DEVICE AND 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).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 80% STENOSED, 24 X 2.75MM TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER THE LESION WAS PREDILATED WITH A 2.5 X 10 MM UNSPECIFIED BALLOON CATHETER, A 2.75X28MM PROMUS ELEMENT¿ PLUS STENT WAS ADVANCED TO TREAT THE LESION, HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE STENT WAS DETACHED/SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460209 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918428270 15835772

    Patients

    Seq Age Sex Outcome Treatment
    1