BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3335881 · Received September 9, 2013

    Report

    Report Number
    2024168-2013-05747
    Event Type
    Injury
    Date Received
    September 9, 2013
    Date of Event
    March 1, 2011
    Report Date
    July 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT AGE ESTIMATED AS (B)(6). PATIENT GENDER ESTIMATED AS MALE. DATE OF EVENT ESTIMATED AS (B)(6) 2011. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE ADDITIONAL DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON REVIEW OF THE ARTICLE, CAUSES OF FAILURE WITH SZABO TECHNIQUE - AN ANALYSIS OF NINE CASES. IT WAS REPORTED THAT FROM (B)(6) 2009 TO (B)(6) 2011, 42 PATIENTS WITH AN OSTIAL LESION WERE TREATED PERCUTANEOUSLY USING SZABO TECHNIQUE IN A MONORAIL STENT SYSTEM. IN 57% OF PATIENTS, DRUG-ELUTING STENTS WERE USED (INCLUDING THE XIENCE V) AND IN 42.8% PATIENTS BARE METAL STENTS (INCLUDING THE ZETA). THE STENT WAS ADVANCED OVER TWO WIRES, THE TARGET WIRE AND THE ANCHOR WIRE. THE ANCHOR WIRES USED INCLUDED THE ALLSTAR GUIDE WIRES AND THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRES. THE TARGET GUIDE WIRES USED INCLUDED THE CROSS IT GUIDE WIRE AND THE MIRACLEBROS GUIDE WIRE. THE PROCEDURE WAS CONSIDERED TO BE SUCCESSFUL IF STENT WAS PLACED PRECISELY COVERING THE LESION AND WITHOUT STENT LOSS OR ANCHOR WIRE PROLAPSING. OF THE TOTAL 42 PATIENTS, THE PROCEDURE WAS SUCCESSFUL IN 33, WHILE FAILED IN 9. FAILURES WERE DUE TO WIRE ENTANGLEMENT, STENT DISLODGMENT (REQUIRING A SNARE DEVICE TO RETRIEVE THE STENT), FAILURE TO CROSS, AND PROLAPSE OF A NON-ABBOTT GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448716 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention