BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 4095524 · Received September 17, 2014

    Report

    Report Number
    2134265-2014-05536
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE STENT HAD DETACHED FROM THE BALLOON. ONLY THE STENT WAS RETURNED FOR ANALYSIS. THE ENTIRE STENT WAS DAMAGED WITH THE STENT STRUTS STRETCHED AND DISTORTED. THE STENT DELIVERY CATHETER WAS NOT RETURNED FOR 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

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH MYOCARDIAL INFARCTION. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 95% STENOSED, 14 MM X 2.5 MM, CONCENTRIC, DE NOVO TARGET LESION CONTAINED <=45 DEGREE BEND AND WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). FOLLOWING THE INSERTION OF A MACH 1 FL 4 6 FR GUIDE CATHETER AND THE ADVANCEMENT OF A NON-BSC GUIDE WIRE, A 2.50MM X 16MM PROMUS ELEMENT¿ PLUS DRUG ELUTING STENT WAS SELECTED FOR USE AND ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED IN ORDER TO PREDILATE THE LESION AND WHILE CLEANING THE STENT DELIVERY SYSTEM, THE PHYSICIAN NOTICED THAT THE STENT WAS NOT MOUNTED. THE STENT WAS FOUND IN THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS STABLE. PATIENT MEDICATIONS POST PROCEDURE WERE ASPIRIN AND CLOPIDOGREL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH MYOCARDIAL INFARCTION. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 95% STENOSED, 14 MM X 2.5 MM, CONCENTRIC, DE NOVO TARGET LESION CONTAINED <=45 DEGREE BEND AND WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). FOLLOWING THE INSERTION OF A MACH 1 FL 4 6 FR GUIDE CATHETER AND THE ADVANCEMENT OF A NON-BSC GUIDE WIRE, A 2.50MM X 16MM PROMUS ELEMENT¿ PLUS DRUG ELUTING STENT WAS SELECTED FOR USE AND ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED IN ORDER TO PREDILATE THE LESION AND WHILE CLEANING THE STENT DELIVERY SYSTEM, THE PHYSICIAN NOTICED THAT THE STENT WAS NOT MOUNTED. THE STENT WAS FOUND IN THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS STABLE. PATIENT MEDICATIONS POST PROCEDURE WERE ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576710 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918416250 16245683

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other MACH 1 FL 4 6 FR GUIDE CATHETER| BMW GUIDE WIRE