BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3961953 · Received July 28, 2014

    Report

    Report Number
    2134265-2014-04477
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND STENT STRUTS ON THE DISTAL END OF THE CRIMPED STENT WAS DISTORTED AND LIFTED UPWARDS FROM THE STENT PROFILE. THIS TYPE OF DAMAGE IS CONSISTENT WITH RESISTANCE BEING ENCOUNTERED WHILE ATTEMPTING TO ADVANCE THE DEVICE TO THE LESION SITE. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. 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 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

    IT WAS REPORTED THAT PROXIMAL STENT DAMAGE OCCURRED. THE 85% STENOSED, ECCENTRIC, DE NOVO, 12 X 3.0 MM TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING(LAD) ARTERY. FOLLOWING THE INTRODUCTION OF A PRE-DILATION, A 3.0 X 12MM PROMUS ELEMENT ¿ DRUG ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, UPON INTRODUCTION, RESISTANCE WAS MET AND THE DEVICE FAILED TO CROSS THE LESION. DEVICE WAS REMOVED AND THE PROXIMAL SEGMENT OF THE STENT WAS NOTED TO HAVE LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PROXIMAL STENT DAMAGE OCCURRED. THE 85% STENOSED, ECCENTRIC, DE NOVO, 12 X 3.0 MM TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING(LAD) ARTERY. FOLLOWING THE INTRODUCTION OF A PRE-DILATION, A 3.0 X 12MM PROMUS ELEMENT ¿ DRUG ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, UPON INTRODUCTION, RESISTANCE WAS MET AND THE DEVICE FAILED TO CROSS THE LESION. DEVICE WAS REMOVED AND THE PROXIMAL SEGMENT OF THE STENT WAS NOTED TO HAVE LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437996 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312300 16062369

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR RUNTHROUGH- GUIDE WIRE