BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 3111095 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03044
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED 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

    SAME CASE AS MDR ID: 2134265-2013-03279 AND 2134265-2013-03280. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A VESSEL DISSECTION AND STENT DAMAGE FOLLOWING DEPLOYMENT OCCURRED. THE SEVERELY STENOSED, DIFFUSE AND FIBROTIC TARGET LESION BEING TREATED WAS LOCATED IN THE SAPHENOUS VEIN GRAFT TO THE RIGHT CORONARY ARTERY. THE LESION WAS PREDILATED WITH A 3.00X30MM MAVERICK BALLOON CATHETER 9 TIMES TO A MAXIMUM OF 12 ATMOSPHERES. A 2.75X38MM ION STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED AND DEPLOYED IN THE DISTAL PART OF THE LESION. A TYPE B DISSECTION WAS THEN NOTED. IT COULD NOT BE CONFIRMED WHETHER THE DISSECTION OCCURRED DURING PREDILATION OR STENT DEPLOYMENT. A 3.00X28MM ION SDS WAS THEN ADVANCED AND DEPLOYED, HOWEVER, THE STENT DID NOT FULLY EXPAND. THE 3.00X28MM ION STENT WAS POST-DILATED WITH A 3.00X15MM QUANTUM APEX BALLOON CATHETER TO 20 ATMOSPHERES. A NON-BSC STENT WAS THEN DEPLOYED IN THE PROXIMAL LESION AND A "CELL DISRUPTION" WAS NOTED IN THE 2.75X38MM ION WHICH IS BELIEVED TO BE STENT DEFORMATION. A 3.00X24MM VERIFLEX SDS WAS THEN ADVANCED AND DEPLOYED IN THE DISTAL LESION TO COMPLETE THE PROCEDURE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THERE WERE NO COMPLICATIONS FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212015 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902438270 0015016144

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention