BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 7078296 · Received December 4, 2017

    Report

    Report Number
    2953200-2017-01915
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    May 5, 2017
    Report Date
    December 4, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    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; A STEERABLE SHEATH TO DEPLOY HYPOGASTRIC BRIDGING STENT BY CONTRALATERAL FEMORAL APPROACH IN AN ILIAC BRANCH PROCEDURE AFTER ENDOVASCULAR ANEURYSM REPAIR CIRO FERRER,1 LUIGI VENTURINI,1 RAFFAELE GRANDE,1 KATIA RACCAGNI,1 LUCA GINANNI CORRADINI,2 MARIO CORONA,2 AND LUCA DI MARZO,1 ROME, ITALY (ANNALS OF VASCULAR SURGERY 2017; 44: 415.E1¿415.E5) HTTP://DX.DOI.ORG/10.1016/J.AVSG.2017.03.200. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED SUCCESSFULLY IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSM REPAIR. THE PATIENT WAS TREATED ELECTIVELY FOR A RECURRENT RIGHT COMMON ILIAC ARTERY ANEURYSM AND STENOSIS FIVE YEARS AFTER EVAR WITH AN ENDURANT DEVICE. THE DISTAL DIAMETER OF THE RIGHT ILIAC LIMB WAS 20MM. A NON-MEDTRONIC IBD WAS IMPLANTED WITH A NON-MEDTRONIC BRIDGING STENT. THIS EFFECTIVELY SEALED THE ANEURYSM. FOLLOW-UP ANGIOGRAPHY SHOWED THE COMPLETE EXCLUSION AND INITIAL SHRINKAGE OF THE ANEURYSM. THE PHYSICIAN STATED THE DILATATION OF THE RIGHT COMMON ILIAC ARTERY SEEMS TO HAVE DEVELOPED AS A PHYSIOLOGICAL ANEURYSMAL DEGENERATION OF A NON-COVERED PORTION OF THE ARTERY, AND WAS MANAGED AS SUCH. IN FACT, NO DISTAL TYPE I ENDOLEAK JEOPARDIZED THE COMPLETE EXCLUSION OF THE AORTIC ANEURYSM. ABSTRACT: ANEURYSMAL DEGENERATION OF DISTAL LANDING ZONES AFTER ENDOVASCULAR ANEURYSM REPAIR (EVAR) CAN BE A POTENTIAL CAUSE OF LATE FAILURE OF THIS TECHNIQUE. ANEURYSMAL DEGENERATION OF COMMON ILIAC ARTERIES INCREASES THE RISK OF RUPTURE OF THE ILIAC ANEURYSM ITSELF AS WELL AS OF THE ABDOMINAL AORTIC ANEURYSM OWING TO ANEURYSM¿S REPERFUSION AS A TYPE IB ENDOLEAK. REOPERATION CONSISTS IN PLUGGING AND COVERING THE INTERNAL ILIAC ARTERY (IIA), BY EXTENSION INTO THE EXTERNAL ILIAC ARTERY, OR PRESERVATION OF ANTE-GRADE FLOW IN IIA BY ILIAC BRANCH DEVICES (IBDS) OR SANDWICH TECHNIQUE. THE MANAGEMENT OF COMMON ILIAC ANEURYSMS AFTER EVAR WITH THE PURPOSE OF PRESERVING ANTE-GRADE FLOW INTO IIA GENERALLY REQUIRES A BRACHIAL OR AXILLARY ACCESS. HOWEVER, THIS APPROACH MAY BE THEORETICALLY ASSOCIATED WITH LOCAL OR SYSTEMIC COMPLICATIONS. WE REPORT A CASE OF IBD IMPLANTATION AFTER EVAR, USING A STEERABLE SHEATH FOR IIA BRIDGING STENT DEPLOYMENT VIA CONTRALATERAL FEMORAL APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857949 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention