BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 2883989 · Received December 21, 2012

    Report

    Report Number
    2953200-2012-02466
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 25, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHODS: (FILM). RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION) 100 OTHER (UNKNOWN CAUSE). CONCLUSION: (UNKNOWN CAUSE).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS 22 MM IN DIAMETER AND 15 MM IN LENGTH. THE RIGHT ILIAC ARTERY WAS 8, 6, 5 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 7, 8, 6 MM IN DIAMETER. THE ILIAC LIMBS ARE SEVERELY CALCIFIED. AT THE INITIAL IMPLANT THE PATIENT HAD A SNORKEL TO THE LEFT RENAL; THE RIGHT RENAL WAS LEFT NATIVE. THE PATIENT RETURNED EMERGENTLY WITH LEG PAIN. THE CT SHOWED RIGHT RENAL ARTERY AND THE LEFT ILIAC ARTERY WAS OCCLUDED. THE PHYSICIAN PERFORMED A THROMBECTOMY IN THE LEFT ILIAC 4 TIMES AND IT KEPT RE-CLOTTING. THE RIGHT RENAL ARTERY WAS LEFT ALONE. THE PATIENT WAS PUT ON COUMADIN IN HOPES THAT IT WOULD TREAT THE OCCLUSIONS. IT WAS REPORTED THAT A WEEK POST INTERVENTION THE PATIENT'S RIGHT RENAL ARTERY WAS STILL OCCLUDED BUT THERE WERE NO CHANGE IN CREATININE LEVEL OR ANY SIGNS OF RENAL COMPROMISE. BOTH ILIAC LIMBS ARE OPEN AND FULLY PATENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE REVIEW OF RETURNED OF THE PRE-IMPLANT 3D RECON IMAGES REVIEWED SHOW THAT THE LEFT RENAL IS LOWER THAN THE RIGHT RENAL. THE DISTAL AORTA MEASURES 15MM AND IS SEVERELY CALCIFIED, AND THE ILIACS ARE STRAIGHT BUT SEVERELY CALCIFIED. THE SEVERELY CALCIFIED ANATOMY MAY HAVE ALSO CONTRIBUTED TO THE ILIAC OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01715078

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention