BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX

    MDR report key: 3746088 · Received April 11, 2014

    Report

    Report Number
    2953200-2014-00692
    Event Type
    Death
    Date Received
    April 11, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ENDURANT AND ANEURX STENT GRAFT SYSTEMS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE DIAMETER OF THE AORTA AT THE LEVEL OF THE RENAL ARTERY WAS 22 MM, LENGTH OF PROXIMAL AORTIC NECK WAS 10 MM, DEGREE OF ANGULATION WAS 30 DEGREES, VESSEL TORTUOSITY WAS MODERATE, AND VESSEL CALCIFICATION WAS MINIMAL. THE LEFT ILIAC WAS APPROXIMATELY 28 MM IN DIAMETER. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN IN THE LEFT SIDE OF THE PELVIS. THE CTA REVEALED A TYPE II ENDOLEAK FROM THE IMA AND SHOWED A DILATED THE LEFT COMMON ILIAC ARTERY WHICH WAS LARGER THAN THE EXISTING LIMB. THE AORTA HAD ALSO DILATED NEAR THE PROXIMAL END OF THE BIFURCATED STENT GRAFT THAT WAS LANDED NEARLY 1 CM DISTAL TO THE LOWEST RENAL AT THE TIME OF IMPLANT. THE CTA DID NOT DEFINITIVELY DISPLAY A PROXIMAL TYPE I ENDOLEAK. THE DECISION WAS MADE TO DO AN ANGIO IN ORDER TO EVALUATE THE PROXIMAL SEAL AS WELL AS EMBOLIZE THE LEFT HYPOGASTRIC ARTERY AND EXTEND THE LIMB INTO THE LEFT EXTERNAL ILIAC. THERE STILL WAS NOT AN OBVIOUS PROXIMAL TYPE I ENDOLEAK, BUT IT WAS DECIDED TO PLACE A PROXIMAL 28X28X49 ENDURANT CUFF UP TO THE LOWEST RENAL AFTER THE LEFT HYPOGASTRIC ARTERY WAS EMBOLIZED WITH A 12 MM STENT GRAFT FROM ANOTHER MANUFACTURER AND THEN EXTENDED FROM THE FLOW DIVIDER OF THE BIFURCATED STENT GRAFT DOWN INTO THE LEFT EXTERNAL ILIAC WITH A 16X13X199 ENDURANT LIMB AS THERE WAS A DISTAL TYPE I ENDOLEAK. BALLOON DILATATION WAS PERFORMED WITH A RELIANT BALLOON. THE FINAL ANGIO SHOWED A BLUSH INTO THE SAC BUT IT APPEARED TO STILL BE BACK FILLING FROM THE IMA. THE PROXIMAL AND DISTAL SEALS APPEARED FINE. THE PHYSICIAN REPORTED THAT THE PATIENT HAD BEEN DOING FINE BUT WAS THEN EXPERIENCING SEVERE ABDOMINAL PAIN. THE PHYSICIAN QUESTIONED BOWEL ISCHEMIA VERSUS THE ENDOLEAK FROM THE IMA. THE PATIENT¿S FAMILY REFUSED FURTHER TREATMENT OR SCANS. THE PHYSICIAN STATED THAT SHORTLY AFTER THAT HE BELIEVED THE PATIENT HAD AN MI AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219883 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00553275

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Death| R