BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTEGE GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD

    MDR report key: 6039579 · Received October 19, 2016

    Report

    Report Number
    2183870-2016-00639
    Event Type
    Death
    Date Received
    October 19, 2016
    Date of Event
    January 1, 2002
    Report Date
    September 20, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    P060001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT EVENT - MEAN AGE/ GENDER- GENDER MAJORITY/ DATE OF EVENT - DATE OF PUBLICATION. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY (2016) 39:1115¿1121 "A RETROSPECTIVE COMPARISON OF ULTRASOUND-ASSISTED CATHETER- DIRECTED THROMBOLYSIS AND CATHETER-DIRECTED THROMBOLYSIS ALONE FOR TREATMENT OF PROXIMAL DEEP VEIN THROMBOSIS". DOI 10.1007/S00270-016-1367-5.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE STUDY IS A RETROSPECTIVE CASE SERIES OF CONSECUTIVE PATIENTS ADMITTED FROM JANUARY 2002 TO JANUARY 2012 WITH ILIOFEMORAL OR VENA CAVA INFERIOR DEEP VEIN THROMBOSIS, WHO WERE TREATED WITH CATHETER-DIRECTED THROMBOLYSIS CDT OR ULTRASOUND-ASSISTED USCDT. VENOUS ACCESS WAS OBTAINED THROUGH POPLITEAL VEIN IN BOTH GROUPS. BALLOON DILATATION AND DEFLATION WERE PERFORMED WHEN DEEMED NECESSARY WHILE EVALUATING TREATMENT RESULT. SELF-EXPANDABLE NITINOL STENTS RANGING IN DIAMETER FROM 10 TO 16 MM WERE USED WHEN DEEMED NECESSARY INCLUDING PROTEGE EV3. AFTER BOTH THROMBOLYTIC PROCEDURES, ANTICOAGULANT THERAPY PROCEEDED WITH STANDARDDVT TREATMENT. 94 PATIENTS WERE INCLUDED WITH AN ILIOFEMORAL OR INFERIOR VENA CAVA DVT, ACCOUNTING FOR 95 EVENTS SINCE ONE PATIENT EXPERIENCED A SECOND DVT. SIXTY-TWO PATIENTS WERE TREATED WITH CDT AND 33 WITH USCDT. OUTCOMES INCLUDED STENOSIS / OCCLUSION /THROMBUS REQUIRING ADDITIONAL INTERVENTION, (BALLOON DILATATION - STENTING) AND DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693611 PROTEGE GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death