BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE ILIAC

    MDR report key: 6020011 · Received October 12, 2016

    Report

    Report Number
    9612164-2016-01080
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    January 1, 2010
    Report Date
    September 13, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    K060057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MONALDI ARCH CHEST DIS 2010; 74: 76-81 FRANCESCO BORGIA, LUIGI DI SERAFINO, ANNA SANNINO, GIUSEPPE GARGIULO, GABRIELE GIACOMO SCHIATTARELLA, MARIO DE LAURENTIS, LAURA SCUDIERO, CINZIA PERRINO, FEDERICO PISCIONE, GIOVANNI ESPOSITO, MASSIMO CHIARIELLO DIVISION OF CARDIOLOGY, FEDERICO II UNIVERSITY OF NAPLES, ITALY. CORRESPONDING AUTHOR: GIOVANNI ESPOSITO MD, PHD; DIVISION OF CARDIOLOGY; FEDERICO II UNIVERSITY; VIA PANSINI, 5; I-80131 NAPLES; ITALY; TEL: +39 081 746 2216; FAX: +39 081 746 2223; E-MAIL ADDRESS: [email protected]. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PERIPHERAL ANGIOGRAPHY CONFIRMED THE PROXIMAL OCCLUSION OF BOTH SUPERFICIAL FEMORAL ARTERY(SFA) AND THE FEMORO-POPLITEAL BYPASS. A CRITICAL STENOSIS OF THE LEFT EXTERNAL ILIAC ARTERY WAS FOUND. IN ORDER TO PERFORM A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY(PTA), 6F LONG SHEATHS WERE POSITIONED 5000 U.I. OF HEPARIN WERE ADMINISTERED INTRAVENOUSLY AND THE POLYTET RAFLUOROETHYLENE (PTFE) GRAFT WAS THEN PASSED WITH A 0.035¿ J-SHAPED STIFF GUIDE-WIRE. THE CRITICAL STENOSIS OF EXTERNAL ILIAC ARTERY WAS TREATED WITH PTA AND STENT IMPLANTATION WITH A COMPLETE 7X40 MM STENT, FOLLOWED BY PTA AND STENTING OF THE DISTAL GRAFT ANASTOMOSIS WITH PROTÉGÉ EVERFLEX. FINAL ANGIOGRAPHY REVEALED OPTIMAL RESULT. THE PATIENT RECEIVED A LOADING DOSE OF CLOPIDOGREL (300 MG) P.O. AND ASA (500 MG) I.V. AND WAS DISCHARGED WITH CLOPIDOGREL (75 MG/DIE) AND ASA (100 MG/DIE). TWO MONTHS LATER, DUPLEX ULTRASOUNDS SCAN DEMONSTRATED A NORMAL FLOW THROUGH THE STENTS AND THE DOWNSTREAM SEGMENTS. AFTER THE PROCEDURE, THE PATIENT WAS ASYMPTOMATIC FOR 4 MONTHS UNDER DUAL ANTIPLATELET THERAPY. HOWEVER, THE PATIENT WAS RECOMMENDED TO STOP CLOPIDOGREL AND TO START WARFARIN ANTICOAGULATION THERAPY IN ADDITION TO ASA, IN ORDER TO PREVENT THROMBOEMBOLIC EVENTS BECAUSE OF THE PERSISTENCE OF ATRIAL FIBRILLATION. CLOPIDOGREL WAS INCORRECTLY INTERRUPTED BEFORE REACHING THERAPEUTIC RANGE OF INR. ONE MONTH LATER, THE PATIENT RETURNED FOR ACUTE LIMB ISCHEMIA(ALI) (FONTAINE¿S STAGE IV). PEDAL PULSES WERE ABSENT AND DUPLEX ULTRASOUND SHOWED ACUTE THROMBOSIS OF BOTH RIGHT PTFE GRAFT AND PREVIOUS IMPLANTED STENT AT THE DISTAL ANASTOMOSIS. ANGIOGRAPHY CONFIRMED THE COMPLETE OCCLUSION OF BOTH BY-PASS AND THE PREVIOUSLY DEPLOYED STENT AT THE DISTAL ANASTOMOSIS. PTA OF RIGHT PTFE BY-PASS WAS PERFORMED BY USING THE CROSSOVER TECHNIQUE. A 0.035¿ J-SHAPED STIFF GUIDE-WIRE WAS CROSSED THROUGH THE LUMEN UP TO THE DISTAL END OF THE TIBIOPERONEAL TRUNKS. MULTIPLE PTAS WERE PERFORMED WITHOUT REACHING ANY GOOD RESULT. FURTHERMORE, THE ANGIOGRAPHY SHOWED MULTIPLE MINUS IMAGES, REVEALING THROMBUS PERSISTENCE. A MECHANICAL THROMBECTOMY WAS PERFORMED ON A 0.014¿ GUIDE-WIRE OBTAINING AN OPTIMAL RESULT UP TO THE DISTAL SEGMENT OF THE BY-PASS. A NEW STENT WAS IMPLANTED IN THE DISTAL FEMORAL POPLITEAL ARTERY IN ORDER TO REACH A BETTER CLINICAL OUTCOME. ONE MONTH AFTER DISCHARGE, PAIN AND WALKING LIMITATIONS DISAPPEARED. SIX MONTHS LATER, COLOUR DOPPLER ULTRASOUND DEMONSTRATED PATENT STENT SEGMENT AND A NORMAL FLOW PATTERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674401 COMPLETE SE ILIAC STENT, ILIAC NIO MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention