BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2032206 · Received March 29, 2011

    Report

    Report Number
    2134265-2011-00898
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED A BREAK IN THE HYPOTUBE 400MM DISTAL TO THE CATHETER STRAIN RELIEF. THERE WERE KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE SHAFT. THE TIP, BALLOON AND STENT SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. MANDREL RESISTANCE WAS ENCOUNTERED DUE TO THE PRESENCE OF SOLIDIFIED BLOOD WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. 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 (B)(6) 2011. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE STENT WOULD NOT CROSS THE LESION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS PROXIMAL-TO-MID LEFT ANTERIOR DESCENDING (LAD). PREDILATION WAS PERFORMED WITH A SEMI-COMPLIANT 1.5X12MM UNKNOWN BALLOON. THE BALLOON WAS UNABLE TO ADVANCE DUE TO CALCIFICATION OF THE LESION. TWO NON-BSC GUIDING CATHETERS WERE ENGAGED TO THE LESION AND THE 2.50X16MM PROMUS ELEMENT STENT WAS ADVANCED, BUT IT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH PLAIN OLD BALLOON ANGIOPLASTY (POBA). NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED A SHAFT BREAK. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316250 13476492

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 12X1.5MM SEMI-COMPLAINT BALLOON| 5FR 5FR HEARTRAIL GUIDING CATHETER| XB GUIDING CATHETER