BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3226959 · Received July 15, 2013

    Report

    Report Number
    2953200-2013-01363
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: OCCLUSION. SHORT NECK AND SHAGGY AORTA, SEVERE THROMBUS. CONCLUSION: OCCLUSION. SHORT NECK AND SHAGGY AORTA, SEVERE THROMBUS.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS 33 MM IN DIAMETER. THE LEFT COMMON ILIAC ARTERY WAS 14MM MM IN DIAMETER AND THE RIGHT COMMON ILIAC ARTERY WAS 15MM IN DIAMETER. THE PATIENT HAS A SHORT NECK AND SHAGGY AORTA. THERE IS SEVERE THROMBUS RIGHT ABOVE RENAL ARTERY, SO RIGHT RENAL ARTERY WAS PROTECTED. DUE TO A SHORT NECK THE PHYSICIAN PLANNED TO DO THE CHIMNEY TECHNIQUE FOR THE LEFT RENAL ARTERY. THE 3620166 WAS DEPLOYED, AND A STENT WAS IMPLANTED IN THE LEFT RENAL ARTERY. THE STENT GRAFT COVERED THE RIGHT RENAL ARTERY TO MAKE THE BEST USE OF THE NECK, AND A STENT WAS IMPLANTED IN THE RIGHT RENAL ARTERY. A 1616124 WAS IMPLANTED ON THE CONTRALATERAL SIDE. IT WAS ABOUT 3CM TO THE BIFURCATED AREA OF LEFT INTERNAL ILIAC ARTERY, AN 161682 WAS IMPLANTED. HOWEVER, THE PHYSICIAN MISJUDGED THE BIFURCATED AREA OF INTERNAL ILIAC ARTERY, WHICH RESULTED IN OCCLUSION OF LEFT INTERNAL ILIAC ARTERY. AFTER THAT, A 202082 WAS ADDED ON THE IPSILATERAL SIDE. THE PROCEDURE WAS COMPLETED. THE PHYSICIAN WILL MONITOR THE PATIENT. THE PATIENT IS FINE AND NO CLINICAL SEQUELAE WERE REPORTED. PHYSICIAN STATED THAT HE MISJUDGED BIFURCATED AREA OF LEFT IIA AND THERE WAS NO CAUSALITY WITH THE RELEVANT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326266 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04043570

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR