BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2922678 · Received January 18, 2013

    Report

    Report Number
    2953200-2013-00128
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    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: INHERENT RISK OF PROCEDURE (ENDOLEAK). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (TAPERED, ANEURYSMAL ILIAC ARTERY). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TAPERED, ANEURYSMAL ILIAC ARTERY).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.8 CM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. THE PROXIMAL AORTIC NECK WAS 25 MM IN DIAMETER, 10 MM IN LENGTH AND 10 DEGREE ANGULATION. THE LEFT COMMON ILIAC ARTERY WAS 14 MM IN DIAMETER AND THE RIGHT COMMON ILIAC ARTERY WAS 16 MM IN DIAMETER. THE RIGHT EXTERNAL ILIAC ARTERY MEASURED 6 MM IN DIAMETER AND THE LEFT EXTERNAL ILIAC ARTERY MEASURED 7 MM IN DIAMETER. IT WAS REPORTED THAT BIFURCATED STENT GRAFT ENBF2816C166EJ WAS DEPLOYED FOLLOWED BY AN ENLW1616C124EJ STENT GRAFT THAT WAS IMPLANTED FOR TREATMENT OF A COMMON ILIAC ARTERY ANEURYSM ON THE IPSILATERAL SIDE. WHEN THE ENLW1616C124EJ WAS DEPLOYED IT APPEARED THERE WAS AN INADEQUATE SEAL DUE TO THE TAPERED COMMON ILIAC ARTERY. AN ANGIOGRAM SHOWED A PROXIMAL TYPE I ENDOLEAK; THEREFORE, AN AORTIC CUFF WAS ADDED; HOWEVER, THERE WAS STILL A SLIGHT ENDOLEAK. THERE WAS ALSO A DISTAL TYPE I ENDOLEAK AT THE CONTRALATERAL LIMB. BALLOONING WAS DONE AGAIN; HOWEVER, THE ENDOLEAK CONTINUED. A TYPE IV ENDOLEAK WAS CONFIRMED AT THE DISTAL END OF THE IPSILATERAL LIMB. THE DECISION WAS MADE TO NOT FURTHER INTERVENE AND TO FOLLOW THE PATIENT FOR THE ENDOLEAKS. THE PHYSICIAN BELIEVES THE SHORT AORTIC NECK IS THE CAUSE OF THE TYPE I ENDOLEAK. THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28199 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01711293

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention