BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1951364 · Received January 6, 2011

    Report

    Report Number
    2134265-2010-05930
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND PROXIMAL STENT DAMAGE. THE PROXIMAL STENT STRUTS WERE MISALIGNED AND STRETCHED OVER THE PROXIMAL MARKERBAND. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. THERE WERE ALSO KINKS IDENTIFIED ALONG THE ENTIRE LENGTH OF THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. 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 TIP AND BALLOON 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. 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

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY (LCX). A 2.50X12MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LCX; HOWEVER, DURING ADVANCEMENT THE PHYSICIAN FELT RESISTANCE AND 'UNUSUAL STENT STRUTS' WERE NOTICED UNDER FLUOROSCOPY. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEFT CIRCUMFLEX ARTERY (LCX) WAS NON-TORTUOUS AND NON-CALCIFIED AND THE LESION WAS PREDILATED WITH A 2.0X15MM MAVERICK BALLOON AT 9ATMS. THE RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE STENT DELIVERY SYSTEM INTO THE STENOSIS. IT WAS NOTED THAT THE STENT STRUTS WERE "PROTRUDING".

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEFT CIRCUMFLEX ARTERY (LCX) WAS NON-TORTUOUS AND NON-CALCIFIED AND THE LESION WAS PREDILATED WITH A 2.0X15MM MAVERICK BALLOON AT 9ATMS. THE RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE STENT DELIVERY SYSTEM INTO THE STENOSIS. IT WAS NOTED THAT THE STENT STRUTS WERE "PROTRUDING".

    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 H7493911312250 13739068

    Patients

    Seq Age Sex Outcome Treatment
    1 6F LAUNCHER GUIDE CATHETER| 2.0X15MM MAVERICK BALLOON CATHETER