BEUDAMED
    FDA Adverse Event Death Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 8292025 · Received January 31, 2019

    Report

    Report Number
    9612164-2019-00368
    Event Type
    Death
    Date Received
    January 31, 2019
    Date of Event
    July 18, 2018
    Report Date
    January 31, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS LITERATURE ARTICLE PUBLISHED DATE JOURNAL ARTICLE TITLE: TRANSRADIAL VERSUS TIBIOPEDAL ACCESS APPROACH FOR ENDOVASCULARINTERVENTION OF SUPERFICIAL FEMORAL ARTERY CHRONIC TOTAL OCCLUSION. CARDIOVASC INTERV. 2018;1¿7. WILEYONLINELIBRARY.COM JOURNAL/CCD VC 2018 WILEY PERIODICALS, INC. / 1 DOI: 10.1002/CCD.27689 PERIPHERAL VASCULAR DISEASE ORIGINAL STUDIES 1338 © 2018 WILEY PERIODICALS, INC. WILEYONLINELIBRARY.COM/JOURNAL/CCD CATHETER CARDIOVASC INTERV. 2018;92:1338¿1344. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BACKGROUND: IMPROVED EQUIPMENT AND TECHNIQUES HAVE RESULTED IN TRANSITION FROM SURGICAL BYPASS TO ENDOVASCULAR INTERVENTION TO TREAT SUPERFICIAL FEMORAL ARTERY (SFA) CHRONIC TOTAL OCCLUSIONS (CTO). A CHANGE IN ACCESS SITE TO RADIAL (TRA) OR TIBIOPEDAL (TPA) ARTERY FOR THE TREATMENT OF THESE SFA CTO HAS BEEN REPORTED. THE FEASIBILITY, EFFICACY AND SAFETY OF THESE TWO ACCESS SITES FOR TREATMENT OF SFA CTO HAVE NOT BEEN REPORTED. THE PRIMARY OBJECTIVE OF THIS STUDY WAS TO COMPARE THE FEASIBILITY, SAFETY AND EFFICACY BETWEEN TRA, TPA AND DUAL TRA-TPA. METHODS: MEDTRONIC DEVICES USED WERE PACIFIC PLUS, PACIFIC XTREME, AND/OR INPACT ADMIRAL. WE PERFORMED AN AS TREATED ANALYSIS OF 184 SFA CTO INTERVENTIONS IN 161 PATIENTS, WITH SYMPTOMATIC PAD (PERIPHERAL ARTERY DISEASE) WHO UNDERWENT ENDOVASCULAR INTERVENTION FOR SFA CTO, FROM 01/2014 TO 09/2016 USING EITHER PRIMARY TRA OR TPA (OPERATOR DISCRETION) AT TWO INSTITUTIONS. PRIMARY END POINT WAS 30-DAY MAJOR ADVERSE EVENT (MAE) - DEATH, AMPUTATION OR TARGET VESSEL REVASCULARIZATION, SECONDARY ENDPOINT WAS SUCCESS OF PROCEDURE. INTERVENTIONS VIA THE TPA WERE PERFORMED USING 4/5/6 FR COMPATIBLE BALLOONS, INCLUDING PACIFIC PLUS/XTREME (MEDTRONIC), AND IN.PACT - UP TO 6 MM (MEDTRONIC). INTERVENTIONS VIA THE TRA WERE PERFORMED USING LONGER SHAFT EQUIPMENT: PACIFIC XTREME PTA BALLOON 180CM (MEDTRONIC). RESULTS: PRIMARY TRA WAS USED IN 46 PATIENTS WITH 47 CTO LESIONS. PRIMARY TPA WAS USED IN 115 PATIENTS WITH 137 CTO LESIONS. PRIMARY CROSSING SUCCESS RATE WAS HIGHER WITH TRA COMPARED TO TPA (74% VS 54%, P 5 0.01). DUAL TRA-TPA WAS REQUIRED IN 72 PRIOR UNCROSSED LESIONS RESULTING IN A CROSSING AND PROCEDURAL SUCCESS OF 99% AND 96% RESPECTIVELY. THE OVERALL CROSSING AND PROCEDURAL SUCCESS RATE USING EITHER OF THESE APPROACHES WAS 99% AND 98% RESPECTIVELY. THE 30-DAY MAE WAS 5% IN TRA ARM (1 PATIENT DEATH AND 1 LIMB AMPUTATION), 0% IN TPA ARM AND 2% IN DUAL TRA-TPA ARM (1 PATIENT DEATH). IN THE DUAL TRA-TPA ARM, THERE WAS ONE CASE OF MINOR DISSECTION (NON-FLOW LIMITING) FOR WHICH A STENT WAS IMPLANTED AND ONE CASE OF MINOR THROMBUS FORMATION IN THE POPLITEAL ARTERY (NON-FLOW LIMITING) FOR WHICH A STENT WAS IMPLANTED. BOTH THESE CASES POST STENT IMPLANTATION SHOWED NO FLOW LIMITATION OR RESIDUAL DISSECTION. ALL ACCESS SITES WERE PATENT, CONFIRMED BY ULTRASOUND. CONCLUSION: THE TREATMENT OF SFA CTO IS FEASIBLE AND SAFE USING BOTH TRA OR TPA APPROACH PROVIDING HIGH SUCCESS RATES AND NO ACCESS SITE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85730 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death