BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAILBLAZER

    MDR report key: 7267201 · Received February 13, 2018

    Report

    Report Number
    2183870-2018-00082
    Event Type
    Injury
    Date Received
    February 13, 2018
    Date of Event
    November 27, 2017
    Report Date
    February 13, 2018
    Manufacturer
    COVIDIEN
    Product Code
    DQY
    PMA / PMN Number
    K092299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS THE 'ARTICLE IN PRESS' DATE SUCCESSFUL RECANALIZATION OF LONG FEMORO-CRURAL OCCLUSIVE DISEASE AFTER FAILED BYPASS SURGERY WORLD JOURNAL OF CARDIOLOGY 9(12): 842-847 2017 DOI: 10.4330/WJC.V9.I12.842. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS ARTICLE DESCRIBES THE TREATMENT OF AN (B)(6) PATIENT WHO PRESENTED WITH ISCHEMIC REST PAIN AND ULCERATION OF THE LEFT LIMB. DUE TO HISTORY OF FAILED BYPASS SURGERY AND SEVERE CARDIO-PULMONARY COMORBIDITIES THE PATIENT WAS SCHEDULED FOR INVASIVE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). AFTER INSERTING A NON-MDT 6F GUIDING CROSS-OVER INTRODUCER SHEATH BY PUNCTURE OF THE RIGHT CFA, DSA CONFIRMED FLUSH OCCLUSION OF THE LEFT SFA WITH NO NATIVE VESSELS DEPICTED IN THE UPPER LEG AND IN THE PROXIMAL LOWER LEG AND WITH SCARCE FILLING OF THE POSTERIOR TIBIAL ARTERY. SUBSEQUENTLY, 500 MG ASPIRIN AND 5000 IU OF HEPARIN WERE INJECTED AND ANTEGRADE RECANALIZATION WAS ATTEMPTED USING DIFFERENT HYDROPHILIC TAPERED AND NON-TAPERED GUIDEWIRES. HOWEVER, ANTEGRADE CROSSING OF THE OCCLUSION FAILED, POSSIBLY DUE TO PRESENCE OF SCARRED TISSUE IN THIS AREA AFTER SURGERY. AFTER CAREFUL REVISION OF THE INITIAL MOVING TABLE NON-DSA ACQUISITION, A STENT WAS IDENTIFIED AT THE LEVEL OF THE MID SFA, WHICH WAS SUBSEQUENTLY DIRECTLY PUNCTURED, FACILITATING THE RETROGRADE INSERTION OF A NON-MDT 0.035¿¿ GUIDEWIRE. RETROGRADE PASSAGE OF A NON-MDT 0.018¿¿ GUIDEWIRE WAS ACHIEVED OVER A 0.035¿¿ TRAILBLAZER SUPPORT CATHETER, WHICH WAS THEN SNARED IN THE 6F GUIDING CROSS-OVER SHEATH. THEN, THE RETROGRADE 0.035¿¿ SUPPORT CATHETER WAS PULLED BACK AND A SECOND ANTEGRADE 0.035¿¿ SUPPORT CATHETER WAS INSERTED OVER THE 6F GUIDING CROSS-OVER SHEATH, WHICH PASSED OVER THE SFA THROUGH THE PUNCTURED STENT AND WAS ADVANCED TO THE LEVEL OF THE POPLITEAL ARTERY. OVER THIS 0.035¿¿ SUPPORT CATHETER, A 0.014¿¿ NON-MDT GUIDEWIRE WAS ADVANCED TO THE PROXIMAL ANTERIOR TIBIAL ARTERY AND ITS INTRALUMINAL LOCALIZATION WAS CONFIRMED BY DSA. BALLOON ANGIOPLASTY WAS THEN PERFORMED USING A 2.5 MM × 200 MM NON-MDT BALLOON IN THE INFRAPOPLITEAL LEVEL AND NON-MDT 5.0 MM × 200 MM AND 6.0 MM × 200 MM IN THE POPLITEAL AND SFA, RESPECTIVELY. DUE TO EXTENSIVE DISSECTION OF THE PROXIMAL SFA A 6.0 MM × 80 MM A SELF-EXPANDING BARE METAL STENT WAS PLACED. THE FINAL ANGIOGRAPHIC RESULT, WAS JUDGED AS SUBOPTIMAL DUE TO THE ABSENCE OF OUTFLOW IN THE LOWER LEG. INTERVENTION WAS STOPPED AT THIS POINT DUE TO CONTRAST AGENT ADMINISTRATION OF APPROXIMATELY 200 ML WITH CHRONIC RENAL DISEASE. THE PATIENT WAS PUT ON TREATMENT WITH 100 MG ASPIRIN, 75 MG CLOPIDOGREL AND 5 MG FONDAPARINUX DAILY AND WAS SCHEDULED FOR RE-ANGIOGRAPHY AFTER 4 WK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111889 TRAILBLAZER CATHETER, PERCUTANEOUS DQY COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention