BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMEGA PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2172984 · Received July 23, 2011

    Report

    Report Number
    2134265-2011-03025
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    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: THE OMEGA STENT DELIVERY SYSTEM (SDS) WAS RECEIVED. THE STENT WAS NOT PRESENT ON THE SDS. THERE WERE STENT STRUT IMPRESSIONS ON THE SURFACE OF THE TIGHTLY FOLDED BALLOON. THE STENT IMPRESSIONS WERE CENTERED BETWEEN THE MARKERBANDS. THERE WAS NO DAMAGE TO THE SDS. 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 DISLODGEMENT AND WITHDRAWAL RESISTANCE OCCURRED. THE 80% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). WHILE ADVANCING A 3.50X20MM OMEGA STENT DELIVERY SYSTEM (SDS) TOWARDS THE TARGET VESSEL THE PHYSICIAN EXPERIENCED RESISTANCE IN ADVANCING IN THE 20% STENOSED AND TORTUOUS PROXIMAL PART OF THE RCA. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE SDS BUT EXPERIENCED WITHDRAWAL RESISTANCE, EVENTUALLY THE SDS WAS ABLE TO BE REMOVED, HOWEVER IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. THE PHYSICIAN WENT BACK INTO THE PROXIMAL RCA AND DILATED THE DISLODGED STENT WITH MULTIPLE BALLOONS TO A DIAMETER OF 3.8MM. THE PROCEDURE WAS COMPLETED WITH THE DEPLOYMENT OF A3.5X15MM AND 3.5X18MM NON-BSC STENTS TO THE MID RCA. IT WAS REPORTED THAT DURING THE WHOLE PROCEDURE THERE WAS NO INFLUENCE TO THE PATIENT AND THE PATIENT'S STATUS 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 REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DISLODGEMENT AND WITHDRAWAL RESISTANCE OCCURRED. THE 80% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). WHILE ADVANCING A 3.50X20MM OMEGA STENT DELIVERY SYSTEM (SDS) TOWARDS THE TARGET VESSEL THE PHYSICIAN EXPERIENCED RESISTANCE IN ADVANCING IN THE 20% STENOSED AND TORTUOUS PROXIMAL PART OF THE RCA. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE SDS BUT EXPERIENCED WITHDRAWAL RESISTANCE, EVENTUALLY THE SDS WAS ABLE TO BE REMOVED, HOWEVER IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. THE PHYSICIAN WENT BACK INTO THE PROXIMAL RCA AND DILATED THE DISLODGED STENT WITH MULTIPLE BALLOONS TO A DIAMETER OF 3.8MM. THE PROCEDURE WAS COMPLETED WITH THE DEPLOYMENT OF A3.5X15MM AND 3.5X18MM NON-BSC STENTS TO THE MID RCA. IT WAS REPORTED THAT DURING THE WHOLE PROCEDURE THERE WAS NO INFLUENCE TO THE PATIENT AND THE PATIENT'S STATUS IS STABLE. 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 H7493913820350 14248597

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention