BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE ALLSTAR GUIDE WIRE

    MDR report key: 1760647 · Received July 14, 2010

    Report

    Report Number
    2024168-2010-01396
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    May 7, 2010
    Report Date
    June 19, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K060449
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE CUSTOMER REPORTED THAT THE GUIDE WIRE WAS DISCARDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: DISSECTION REQUIRING INTERVENTION. ONSET OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS REPORTED VIA TRIAL THAT ON (B) (6)2007, THE PT UNDERWENT STENTING IN THE PREDILATED MID RIGHT CORONARY ARTERY (RCA) WITH TWO XIENCE V STENTS AND THE PREDILATED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH ONE XIENCE V STENT. THE SECOND RCA XIENCE V STENT WAS IMPLANTED FOR TREATMENT A DISSECTION DISTAL TO THE TARGET LESION THAT WAS IDENTIFIED AFTER POST DILATATION AND WAS CAUSED BY A ALLSTAR GUIDE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE ALLSTAR GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention XIENCE V (1009551-18, LOT 60617P3)| STENT: XIENCE V (PART 1009553-28, LOT 60601PI)