BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 2223216 · Received August 25, 2011

    Report

    Report Number
    2134265-2011-03549
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE TAXUS ELEMENT/ ION STENT WAS DETACHED FROM THE STENT DELIVERY SYSTEM (SDS), AS-RECEIVED, AND ONE END OF THE STENT WAS ENTANGLED WITH AN UNIDENTIFIED GUIDE WIRE. THE ENTIRE LENGTH OF THE STENT WAS STRETCHED. THE BALLOON OF THE SDS WAS LOOSELY FOLDED. THERE WAS NO DAMAGE TO THE SDS. THE CONDITION OF THE RETURNED DEVICES WAS CONSISTENT WITH THE REPORTED GUIDEWIRE-STENT INTERACTION AND RESULTING INADVERTENT REMOVAL OF THE STENT. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE COMPLAINT EVENT. 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 A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM - REMOVING THE FOLLOWING STATEMENT - "SAME CASE AS MFR# 2134265-2011-03550".

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2011-03550. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT EXPLANT OCCURRED. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 85% STENOSED, 2.75X18MM, CONCENTRIC, DE NOVO LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS, NON-CALCIFIED OSTIAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 2.0X12MM NON-BSC BALLOON. THE PHYSICIAN SUCCESSFULLY IMPLANTED A 2.25X12MM ION STENT IN THE DISTAL RCA AND A 2.5X20MM ION STENT IN THE OSTIUM OF THE RCA. THE NON-BSC GUIDE WIRE WAS REMOVED. THE PHYSICIAN ATTEMPTED TO PLACE AN UNKNOWN GUIDE WIRE IN ORDER TO POSTDILATED THE 2.5X20MM ION STENT, BUT THE GUIDE WIRE KEPT GETTING TANGLED UNDER THE 2.5X20MM ION STENT. UPON WITHDRAWAL OF THE UNKNOWN GUIDE WIRE THE 2.5X20MM ION STENT WAS EXPLANTED. A NON-BSC GUIDE WIRE WAS PLACED AND A 2.75X20MM ION STENT WAS SUCCESSFULLY IMPLANTED. MEDICATIONS GIVEN INCLUDED: PLAVIX AND ANGIOMAX. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT EXPLANT OCCURRED. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 85% STENOSED, 2.75X18MM, CONCENTRIC, DE NOVO LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS, NON-CALCIFIED OSTIAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 2.0X12MM NON-BSC BALLOON. THE PHYSICIAN SUCCESSFULLY IMPLANTED A 2.25X12MM ION STENT IN THE DISTAL RCA AND A 2.5X20MM ION STENT IN THE OSTIUM OF THE RCA. THE NON-BSC GUIDE WIRE WAS REMOVED. THE PHYSICIAN ATTEMPTED TO PLACE AN UNKNOWN GUIDE WIRE IN ORDER TO POSTDILATE THE 2.5X20MM ION STENT, BUT THE GUIDE WIRE KEPT GETTING TANGLED UNDER THE 2.5X20MM ION STENT. UPON WITHDRAWAL OF THE UNKNOWN GUIDE WIRE, THE 2.5X20MM ION STENT WAS EXPLANTED. A NON-BSC GUIDE WIRE WAS PLACED AND A 2.75X20MM ION STENT WAS SUCCESSFULLY IMPLANTED. MEDICATIONS GIVEN INCLUDED: PLAVIX AND ANGIOMAX. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2011-03550. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT EXPLANT OCCURRED. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 85% STENOSED, 2.75X18MM, CONCENTRIC, DE NOVO LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS, NON-CALCIFIED OSTIAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 2.0X12MM NON-BSC BALLOON. THE PHYSICIAN SUCCESSFULLY IMPLANTED A 2.25X12MM ION STENT IN THE DISTAL RCA AND A 2.5X20MM ION STENT IN THE OSTIUM OF THE RCA. THE NON-BSC GUIDE WIRE WAS REMOVED. THE PHYSICIAN ATTEMPTED TO PLACE AN UNKNOWN GUIDE WIRE IN ORDER TO POSTDILATED THE 2.5X20MM ION STENT, BUT THE GUIDE WIRE KEPT GETTING TANGLED UNDER THE 2.5X20MM ION STENT. UPON WITHDRAWAL OF THE UNKNOWN GUIDE WIRE THE 2.5X20MM ION STENT WAS EXPLANTED. A NON-BSC GUIDE WIRE WAS PLACED AND A 2.75X20MM ION STENT WAS SUCCESSFULLY IMPLANTED. MEDICATIONS GIVEN INCLUDED: PLAVIX AND ANGIOMAX. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902420250 14394885

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention KINETIX GUIDE WIRE| 6FR RUNWAY JR4 WITH SIDEHOLES| BMW GUIDE WIRE