BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2968816 · Received February 19, 2013

    Report

    Report Number
    2953200-2013-00298
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 24, 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). EVALUATION RESULTS AND CONCLUSION: (VESSEL PERFORATION). (TORTUOUS ILIAC ARTERY).

    Description of Event or Problem · 1

    AN ENDURANT ILIAC STENT GRAFT WAS ATTEMPTED TO BE INSERTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A LEFT COMMON ILIAC ARTERY ANEURYSM APPROXIMATELY THREE WEEKS AGO. THE PATIENT PREVIOUSLY HAD STENT GRAFTS PLACED FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND THIS WAS THE PATIENT'S FOURTH ABDOMINAL PROCEDURE. NONE OF THE PREVIOUSLY IMPLANTED STENT GRAFTS WERE MEDTRONIC PRODUCTS AND DETAILS ON THE PREVIOUS PROCEDURES ARE NOT AVAILABLE. ANOTHER MANUFACTURER'S GUIDE WIRE WAS INSERTED FROM THE LEFT ARM TO THE LEFT FEMORAL ARTERY. THE STENT GRAFT DELIVERY SYSTEM WAS ADVANCED OVER THE GUIDE WIRE WITH A PULL-THROUGH TECHNIQUE. THE NOSE CONE WAS SUCCESSFULLY ADVANCED; HOWEVER, THE BASE OF THE NOSE CONE WAS NOT ABLE TO BE ADVANCED DUE TO THE VESSEL TORTUOSITY. THE PHYSICIAN ABORTED THE PULL-THROUGH TECHNIQUE. A LUNDERQUIST WIRE WAS THEN INSERTED FROM THE LEFT FEMORAL ARTERY BUT IT WAS NOT ABLE TO BE ADVANCED DUE TO THE VESSEL TORTUOSITY. THE PHYSICIAN PERFORMED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY IN THE AREA OF TORTUOUSITY WITH ANOTHER MANUFACTURER'S BALLOON CATHETER AND AGAIN TRIED TO ADVANCE THE STENT GRAFT WITH A PULL-THROUGH TECHNIQUE, BUT THE BASE OF THE NOSE CONE STILL COULD NOT PASS THE TORTUOUS AREA. WHILE ATTEMPTING TO PUSH THE DEVICE SEVERAL TIMES THE GRAFT COVER KINKED AT THE STENT GRAFT STOP AND THE LEFT EXTERNAL ILIAC ARTERY RUPTURED JUST BELOW THE BIFURCATION OF THE INTERNAL ILIAC ARTERY. THE PHYSICIAN IMPLANTED ANOTHER MANUFACTURER'S LIMB FROM THE DISTAL END OF THE COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY AS AN EMERGENCY TREATMENT. THIS SUCCESSFULLY STOPPED THE BLEEDING. THE ENDURANT 162882 WAS NOT IMPLANTED AND THE PHYSICIAN COMPLETED THE PROCEDURE. A FEM-FEM BYPASS IS PLANNED AT A LATER DATE. NO FURTHER INFORMATION WAS PROVIDED. THE DELIVERY SYSTEM WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71824 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00965207

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention