BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3232190 · Received July 17, 2013

    Report

    Report Number
    2953200-2013-01376
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 20, 2013
    Report Date
    September 2, 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 CONCLUSIONS: (OCCLUSION). (NARROW ILIAC ARTERIES). (ILIAC DIAMETER 8MM).

    Additional Manufacturer Narrative · 1

    METHOD: FILM EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT WAS SUCCESSFULLY TREATED WITH A FEM-FEM BYPASS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    CTA'S 6-DAYS POST-IMPLANT SHOWED THAT THE BIFURCATE WAS POSITIONED JUST BELOW THE RENAL ARTERY. THE STENT GRAFT OD AT THE PROXIMAL MARGIN WAS 23X24MM, AND 1CM DISTALLY WAS 26MM OD. THE IPSILATERAL LIMB + EXTENSION WERE PLACED INTO THE LEFT COMMON ILIAC, AND A SINGLE CONTRA LIMB WAS PLACED INTO THE RIGHT COMMON ILIAC. THE RIGHT CONTRA LIMB (AND BIFUR GATE) WERE OCCLUDED DISTALLY FROM THE FLOW DIVIDER, WITH BLOOD FLOW RESUMING WITHIN THE LAST STENT OF THE CONTRALATERAL LIMB. THE LEFT/IPSILATERAL LIMB WAS PATENT. NEAR THE 18MM DIAMETER DISTAL AORTA THE CONTRA LIMB WAS SEEN COMPRESSED DOWN NEARLY FLAT (<(><<)>2MM). THE ID OF THE PATENT IPSI LIMB MEASURED 12-13MM WITHIN THE DISTAL AORTA. THE DISTAL CONTRA LIMB (WHERE THE FLOW RESUMED) MEASURED 8MM ID, AND THE RIGHT EXTERNAL ILIAC ID MEASURED 4-5MM. IT IS LIKELY THAT THE SEVERE STENT GRAFT COMPRESSION FROM THE RADIALLY STRONGER OPPOSING IPSI LIMB, WITHIN THE SMALL DISTAL AORTA, CAUSED THE OCCLUSION. THE SMALL RIGHT EXTERNAL ILIAC MAY HAVE ALSO CONTRIBUTED TO THE POOR OUTFLOW.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 50.8 MM IN DIAMETER AND 104 MM IN LENGTH ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS 24 MM IN DIAMETER AND 15 MM IN LENGTH. THE LEFT COMMON ILIAC ARTERY WAS 7.6MM MM IN DIAMETER AND THE RIGHT COMMON ILIAC ARTERY WAS 8MM IN DIAMETER. THE RIGHT EXTERNAL ILIAC ARTERY MEASURED 5.4MM IN DIAMETER AND THE LEFT EXTERNAL ILIAC ARTERY MEASURED 9.1MM IN DIAMETER. THE RIGHT INTERNAL ILIAC ARTERY WAS 6.8MM IN DIAMETER; THE LEFT WAS 7.5 MM IN DIAMETER. BOTH CIA DIAMETERS WERE NARROW, BUT THERE WAS NEITHER PTA NOR IMPLANT OF BARE STENT DURING EVAR. IT WAS REPORTED THAT THE PATIENT HAD A LIMB OCCLUSION ON THE LEFT SIDE. THE PATIENT MAY BE TREATED BY FEMORAL-FEMORAL BYPASS AT A LATER DATE. THE PHYSICIAN¿S COMMENTS STATE THAT THE LEFT SIDE HAS A DOUBLED GRAFT SO THAT IT IS POSSIBLE THAT IT MAY BE COMPRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330460 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04010727

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention