BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3081459 · Received April 29, 2013

    Report

    Report Number
    2953200-2013-00791
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) METHOD: (FILMS), RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, RUPTURE), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (MODERATE CALCIFIED ARTERIES AND DISEASED ANEURYSM REMODELLING), CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (MODERATE CALCIFIED ARTERIES AND DISEASED ANEURYSM REMODELLING).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT IS UNKNOWN. CURRENT ANEURYSM SIZE IS 8.6 CM AND VESSEL MORPHOLOGY WAS REPORTED AS MODERATE CALCIFIED. THE AORTIC NECK DIAMETER AT THE RENAL ARTERY AND ABOVE THE ANEURYSM WAS 31.5 MM. THE SUPRARENAL ANGULATION WAS 35 DEGREES AND THE INFRARENAL ANGULATION WAS 40 DEGREES. THE CONFIGURATION OF THE AORTIC NECK WAS INVERTED CONICAL. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED IN THE EMERGENCY ROOM WITH ABDOMINAL PAIN AND A CT SCAN REVEALED EVIDENCE OF BLOOD IN THE ABDOMINAL CAVITY. THE PHYSICIAN STATED A POSSIBLE TYPE III ENDOLEAK (MODULAR DISCONNECTION) IN THE LEFT ILIAC LIMB/EXTENSION; HOWEVER, THERE IS NO ADDITIONAL INFORMATION ON THE PRIMARY CAUSE OF THE ENDOLEAK. THE PATIENT DID NOT HAVE REGULAR FOLLOW UP VISITS. THE PHYSICIAN TREATED THE TYPE III ENDOLEAK AND IMPLANTED AN ENDURANT (LEFT SIDE) STENT GRAFT AND THE ENDOLEAK WAS RESOLVED. THE PATIENT IS FINE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. A REVIEW OF RETURNED ANGIO IMAGES AT IMPLANT SHOWED THAT THE BIFURCATE WAS PLACED WITH THE IPSILATERAL LIMB AND EXTENSION INTO THE RIGHT COMMON ILIAC ARTERY; THE IPSI LIMBS WERE OVERLAPPING APPROXIMATELY 20 MM. ON THE LEFT SIDE, THE CONTRALATERAL LIMB AND EXTENSION WERE PLACED INTO THE LEFT COMMON ILIAC ARTERY, WITH APPROXIMATELY 20 - 25 MM OF COMPONENT OVERLAP (PER THE LIMB MARKERS). BOTH LIMBS APPEAR ESSENTIALLY STRAIGHT IN THE OVERLAPPING LIMB SECTIONS. POST-IMPLANT IMAGES SHOW A PROBABLE TYPE III JUNCTIONAL ENDOLEAK BETWEEN THE CONTRALATERAL LIMB AND CONTRA EXTENSION. THE AMOUNT OF CONTRALATERAL COMPONENT OVERLAP APPEARS TO HAVE BEEN REDUCED; NOW MEASURES APPROXIMATELY 2 MM (NEARLY LINE-TO-LINE) MEDIALLY TO 10 MM LATERALLY. THE CONTRA LIMBS ARE MORE BOWED-SHAPED AND THE LEFT ILIAC APPEARS SLIGHTLY MORE ANGULATED LATERALLY AT ITS DISTAL END; COMPARED TO THE IMAGES POST-IMPLANT. THE OVERLAP ACROSS THE IPS ILATERAL COMPONENTS IS STILL 20 MM. AFTER IMPLANTING A LIMB ACROSS THE LEFT/CONTRA JUNCTION THE ENDOLEAK RESOLVED. THE CAUSE OF THE TYPE III SEPARATION ENDOLEAK COULD NOT BE CONFIRMED; IT IS POSSIBLE THAT IT WAS CAUSED BY ANEURYSM REMODELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183625 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00434189

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention