BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAILBLAZER

    MDR report key: 6293692 · Received February 1, 2017

    Report

    Report Number
    2183870-2017-00052
    Event Type
    Injury
    Date Received
    February 1, 2017
    Date of Event
    October 15, 2016
    Report Date
    January 4, 2017
    Manufacturer
    COVIDIEN
    Product Code
    DQY
    PMA / PMN Number
    K092299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDIAN AGE = 56 (RANGE 29-80 YEARS). GENDER = 17/24 MALE. JOURNAL ARTICLE TITLE: OUTCOMES OF STENT PLACEMENT FOR CHRONIC OCCLUSION OF A FILTER-BEARING INFERIOR VENA CAVA IN PATIENTS WITH SEVERE POST-THROMBOTIC SYNDROME. K. YE, X. LU, W. LI, M. YIN, X. LIU, J. QIN, G. LIU, M. JIANG EUR J VASC ENDOVASC SURG (2016) 52, 839E846 .

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A RETROSPECTIVE ANALYSIS OF 24 PATIENTS WITH SEVERE PTS ASSOCIATED WITH OCCLUSION OF A FILTER-BEARING IVC TREATED BY STENT PLACEMENT WAS CONDUCTED AT A SINGLE INSTITUTION. AFTER VEIN PUNCTURE WAS SUCCESSFULLY ACHIEVED, HEPARIN SODIUM (80 IU/KG) WAS ADMINISTERED TO ACHIEVE AN ACTIVATED CLOTTING TIME OF 250E300 S IN ALL PATIENTS. BRIEFLY, A STRAIGHT STIFF 0.035-INCH HYDROPHILIC GUIDE WIRE WAS DIRECTED THROUGH THE OCCLUSION OF THE ILIOFEMORAL VEIN UNDER THE GUIDANCE OF A MATCHED MULTIPURPOSE CATHETER OR TRAILBLAZER CATHETER. THEN, THE GUIDE WIRE WAS USED TO TRACK ALONG THE IVC CENTRALLY UNTIL THE OCCLUSION OF THE FILTER-BEARING IVC HAD BEEN CROSSED. ALL PATIENTS TOLERATED THE PROCEDURE WELL, AND NO MAJOR COMPLICATIONS WERE ENCOUNTERED. SPECIFICALLY, NO PERIOPERATIVE DEATHS OR SYMPTOMATIC PE OCCURRED. THERE WAS NO CLINICALLY APPARENT PROCEDURE-RELATED BLEEDING, AND NO ACCESS COMPLICATIONS REQUIRING INTERVENTION, AND NO FILTER PERFORATION OCCURRED DURING FOLLOW-UP OF VENOUS CT ANGIOGRAPHY. MINOR COMPLICATIONS INS SOME PATIENTS INCLUDING VENOUS PERFORATION. VENOUS PERFORATION WAS RESOLVED IN ALL CASES WITHOUT SEQUELAE AFTER BALLOON ANGIOPLASTY AND STENT PLACEMENT FOR THE OCCLUDED FILTER-BEARING IVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75991 TRAILBLAZER CATHETER, PERCUTANEOUS DQY COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention