BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 7078290 · Received December 4, 2017

    Report

    Report Number
    2953200-2017-01913
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    January 17, 2017
    Report Date
    December 4, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; EMBO-EVAR: A TECHNIQUE TO PREVENT TYPE II ENDOLEAK? A SINGLE-CENTER EXPERIENCE. MASSIMILIANO NATRELLA, ALESSANDRO RAPELLINO, FEDERICO NAVARRETTA, GIANLUCA IOB, MASSIMO CRISTOFERI, MATTEO CASTAGNOLA, GIANMARCO LUNARDI, LUCA DUC, GIANLUCA FANELLI, ANDREA PERUZZO CORNETTO, TEODORO MELONI, AND FLAVIO PEINETTI. ANN VASC SURG 2017; 44: 119¿127 HTTP://DX.DOI.ORG/10.1016/J.AVSG.2017.01.028 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT IN THE ABDOMINAL AORTIC ANEURYSM, PARARENAL ANEURYSMS, AND ANEURYSMS INCLUDING THE ILIAC ARTERIES. EVENTS REPORTED IN THE JOURNAL ARTICLE: PROXIMAL TYPE I ENDOLEAK AND DISTAL TYPE I ENDOLEAK AND RENAL FAILURE. BACKGROUND: INTRAPROCEDURAL ANEURYSM SAC EMBOLIZATION (EMBO-EVAR) DURING ENDOVASCULAR ABDOMINAL ANEURYSM REPAIR (EVAR) USING COILS AND FIBRIN GLUE IS A TECHNIQUE FOR PREVENTING TYPE II ENDOLEAK (EII). OUR AIM IS TO EVALUATE FEASIBILITY, SAFETY AND CLINICAL OUTCOME OF THIS PROMISING APPROACH. MATERIALS AND METHODS: A RETROSPECTIVE CLINICAL CASE ANALYSIS OF 72 PATIENTS WHO UNDERWENT EVAR DURING THE PERIOD 2011/2014. TWO GROUPS WERE COMPARED AT 6 AND 12 MONTHS FOLLOW-UP WITH CONTRAST MEDIA COMPUTED TOMOGRAPHY SCAN AND CONTRAST-ENHANCED ULTRASOUND (CEUS) IMAGING: CONSECUTIVELY, 36 PATIENTS (GROUP A) TREATED WITH CLASSIC EVAR AND 36 PATIENTS (GROUP B) TREATED WITH EMBO-EVAR. COILS WERE RELEASED FILLING BETTER AS POSSIBLE THE ANEURYSM SAC; THE EMBOLIZATION WAS COMPLETED BY INJECTING FIBRIN GLUE. DEVICE AND MATERIALS USED, DIFFERENTIAL SYSTEMIC AND SAC PRESSURES, PRESENCE OF ANY ENDOLEAK, AND COMPLICATION WERE REGISTERED. RESULTS: IN OUR EXPERIENCE, WE HAD 100% TECHNICAL SUCCESS WITHOUT SURGICAL CONVERSION. EMBO-EVAR WAS PERFORMED, AFTER ENDOGRAFT DEPLOYMENT, IN GROUP B PATIENTS, ALL WITH RATIO OF D-PRESSURES (OBTAINED FROM D-SAC PRESSURE/D-DIFFERENTIAL PRESSURE) > 0.16. NO EARLY OR LATE COMPLICATIONS OCCURRED, AND MORTALITY WAS NIL. FOLLOW-UP WAS PERFORMED WITH COMPUTED TOMOGRAPHY-ANGIOGRAPHY AND CEUS AT 6 AND 12 MONTHS. WE OBSERVED 9 TYPE II AND 1 TYPE IA ENDOLEAK IN GROUP A AND 2 TYPE II AND 1 TYPE IB ENDOLEAKS IN GROUP B. MEAN RADIATION EXPOSURE TIME WAS 30.3 MIN IN GROUP A AND 43.3 MIN IN GROUP B. EVAR PROCEDURE AVERAGE COST WAS 9,000 V. THE AVERAGE COST OF SAC EMBOLIZATION WAS 1,500. CONCLUSIONS: ALTHOUGH A RANDOMIZED STUDY IS NECESSARY, EMBO-EVAR MAY BE A VALID APPROACH TO PREVENT TYPE II ENDOLEAKS AND FURTHER COMPLICATIONS. MILD COSTS AND EXPOSURE DOSE INCREASE COULD BE ACCEPTED TO AVOID RE-INTERVENTIONS, AND IN OUR EXPERIENCE, IT COULD BE ROUTINELY PERFORMED WITH EXCELLENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857944 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR