BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT SYSTEM

    MDR report key: 2981663 · Received February 27, 2013

    Report

    Report Number
    2953200-2013-00352
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P1000212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK. PRE-OPERATIVELY RUPTURED ANEURYSM AND DISSECTED ILIAC ARTERIES. TREATMENT OF A PATIENT WITH PRE-OPERATIVELY RUPTURED ANEURYSM AND DISSECTED ILIAC ARTERY. CONCLUSION: PRE-OPERATIVELY RUPTURED ANEURYSM AND DISSECTED ILIAC ARTERIES. TREATMENT OF A PATIENT WITH PRE-OPERATIVELY RUPTURED ANEURYSM AND DISSECTED ILIAC ARTERY.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A PRE-OPERATIVELY RUPTURED ABDOMINAL AORTIC ANEURYSM AND DISSECTION NEAR THE LEFT COMMON ILIAC ARTERY APPROXIMATELY THREE WEEKS AGO. IT WAS REPORTED THAT THE PHYSICIAN COILED THE LEFT INTERNAL ILIAC ARTERY IMPLANTED THE ENDURANT STENT GRAFTS AND CLOSED THE CUT DOWN AREA. AT THIS TIME THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN OPENED THE ABDOMEN AND LOCATED THE SOURCE OF THE BLEEDING. THE FEMORAL ARTERY WAS THEN OPENED AND THE OVERLAP BETWEEN THE IPSILATERAL LIMB AND IPSILATERAL EXTENSION WAS BALLOONED. THE PATIENT'S BLOOD PRESSURE INCREASED. ANOTHER MANUFACTURER'S STENT GRAFT WAS IMPLANTED AT THE JUNCTION BETWEEN THE TWO ENDURANT STENT GRAFTS. THE BLOOD PRESSURE STABILIZED AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN BELIEVES THE BLEEDING WAS DUE TO A TYPE III OR TYPE IV ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84042 ENDURANT ABDOMINAL STENT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V1730768

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention