BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2880503 · Received December 19, 2012

    Report

    Report Number
    2953200-2012-02444
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    March 28, 2013
    Report Date
    November 21, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (VESSEL PERFORATION). INCORRECT TECHNIQUE/PROCEDURE (TREATMENT OF A PATIENT WITH AN AORTIC NECK THAT IS LESS THAN 19 MM IN DIAMETER). CAUSED BY ANOTHER DRUG/DEVICE (GUIDE WIRE). CONCLUSION: ANOTHER DEVICE CAUSED FAILURE (GUIDE WIRE). OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (TREATMENT OF A PATIENT WITH AN AORTIC NECK THAT IS LESS THAN 19 MM IN DIAMETER).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.2 CM DIAMETER FUSIFORM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. THE PROXIMAL NECK WAS 18-15 MM IN DIAMETER AND 17 MM IN LENGTH. THE AORTIC NECK ANGULATION WAS 60 DEGREES. PRIOR TO THE ENDOVASCULAR PROCEDURE, THE PATIENT HAD A FEM-FEM BYPASS. THE RIGHT ILIAC ARTERY HAD CHRONIC TOTAL OCCLUSION FROM THE RIGHT COMMON ILIAC ARTERY TO THE RIGHT FEMORAL ARTERY. BEFORE THE EVAR PROCEDURE, THE PHYSICIAN PERFORMED A THROMBECTOMY WITH A FOGARTY CATHETER TO PASS THE RIGHT CHRONIC OCCLUSION AND IT WAS SUCCESSFUL. IN ORDER TO IMPLANT THE BIFURCATED STENT GRAFT, THE PHYSICIAN TRIED TO INSERT A GUIDE WIRE THROUGH THE ILIAC ARTERY; HOWEVER, THE GUIDE WIRE WENT INTO THE FALSE LUMEN. THE PHYSICIAN ADVANCED A SHEATH FROM THE LEFT SIDE AND LOCATED THE TRUE LUMEN WITH A SNARE CATHETER. AT THAT TIME, AN ANGIO REVEALED THERE WAS BLEEDING FROM THE VESSEL NEAR THE LEFT COMMON ILIAC ARTERY WHICH INDICATED THE VESSEL PERFORATED. THE PHYSICIAN IMPLAN TED THE MAIN BODY AND THE IPSILATERAL LIMB WAS EXTENDED TO LEFT EXTERNAL ILIAC ARTERY. THE CONTRALATERAL LIMB WAS EXTENDED TO NEAR THE BIFURCATION OF THE LEFT FEMORAL ARTERY TO DILATE THE TRUE LUMEN. ON FINAL ANGIO NO ENDOLEAK WAS OBSERVED AND THE PATIENT¿S BLOOD PRESSURE WAS STEADY. THE PHYSICIAN STATED THAT THIS EVENT WAS NOT RELATED TO ENDURANT DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01689341¿

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention