BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2141735 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02465
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED STENT DAMAGE. THERE WAS A BLOOD LIKE SUBSTANCE VISIBLE ON THE OUTER SURFACE OF THE DEVICE. TWO STRUTS IN THE FIRST PROXIMAL ROW WERE BENT BACK DISTALLY AND TWO STRUTS IN THE SECOND PROXIMAL ROW WERE SLIGHTLY LIFTED. THERE WAS NO OTHER DAMAGE TO THE DEVICE. 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 DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE AND STENT MOVED ON BALLOON OCCURRED. ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE 12X3.0MM, ECCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER PREDILATING THE LESION, A 12X3.0MM OMEGA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION. THE STENT WAS PULLED BACK INTO THE GUIDE CATHETER AND IT WAS NOTED THAT THE STENT WAS DAMAGED. THE STENT REMAINED CRIMPED ON THE DELIVERY SYSTEM, HOWEVER SOME OF THE STRUTS HAD MOVED AWAY FROM THE BALLOON. A NON-BSC SDS WAS ALSO ADVANCED BUT IT COULD NOT CROSS THE LESION. THE PHYSICIAN HAD TREATED ADDITIONAL LESIONS SUCCESSFULLY AND DECIDED TO CLOSE THE CASE WITHOUT PLACING AN ADDITIONAL STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THE PATIENT WILL BE ON ASPIRIN AND PLAVIX FOR THE NEXT YEAR. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE AND STENT MOVED ON BALLOON OCCURRED. ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE 12X3.0MM, ECCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER PREDILATING THE LESION, A 12X3.0MM OMEGA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION. THE STENT WAS PULLED BACK INTO THE GUIDE CATHETER AND IT WAS NOTED THAT THE STENT WAS DAMAGED. THE STENT REMAINED CRIMPED ON THE DELIVERY SYSTEM, HOWEVER SOME OF THE STRUTS HAD MOVED AWAY FROM THE BALLOON. A NON-BSC SDS WAS ALSO ADVANCED BUT IT COULD NOT CROSS THE LESION. THE PHYSICIAN HAD TREATED ADDITIONAL LESIONS SUCCESSFULLY AND DECIDED TO CLOSE THE CASE WITHOUT PLACING AN ADDITIONAL STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THE PATIENT WILL BE ON ASPIRIN AND PLAVIX FOR THE NEXT YEAR. 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 OMEGA PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493913812300 14189359

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR LAUNCHER 6F JL4 GUIDE CATHETER (MEDTRONIC)| BMW GUIDEWIRE (ABBOTT)