BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3100399 · Received May 8, 2013

    Report

    Report Number
    2953200-2013-00857
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHODS: (FILMS). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK ); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; ANGULATED AND CONICAL AORTIC NECK). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; ANGULATED AND CONICAL AORTIC NECK).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF 5.2 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED THAT THERE WAS MILD TORTUOSITY AND MODERATE CALCIFICATION THROUGHOUT THE VESSELS. IT WAS REPORTED THAT THE STENT GRAFTS WERE IMPLANTED IN THE PATIENT. THE ANGIOGRAM REVEALED A POSSIBLE TYPE III ENDOLEAK, FABRIC AT THE FLOW DIVIDER ON THE CONTRALATERAL GATE SIDE. THE ILIAC LIMBS WERE CROSSED AT THE TIME OF IMPLANT. THE PHYSICIAN IMPLANTED TWO 16X16X82 BILATERALLY, HOWEVER THE TYPE III ENDOLEAK DID NOT COMPLETELY RESOLVE. THE PHYSICIAN PERFORMED A KISSING BALLOONS WHERE DONE ACROSS AREA MULTIPLE TIMES, HOWEVER THERE WAS STILL A SLOW PERSISTENCE ENDOLEAK THAT REMAINED. THERE ALSO APPEARED TO BE A STENT STRUT PROTRUDING OUT, THE LOCATION OF THE PROTRUDING STRUT WAS 5 CM DISTALLY ON THE BIFURCATED STENT GRAFT. THERE WAS NO FURTHER TREATMENT AT THIS TIME, THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. A CT WAS PERFORMED THREE DAYS LATER AND THE ENDOLEAK HAD RESOLVED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF RETURNED FILMS PRE-IMPLANT SHOWED A CALCIFIED NECK AND ABDOMINAL AORTIC ANEURYSM. THERE IS A LIKELY A DISSECTION FLAP ON THE ANTERIOR SIDE OF THE PROXIMAL AORTIC NECK. THE AORTIC NECK DIAMETER (FLOW LUMEN) MEASURES 20 X 21MM BELOW THE RENAL ARTERIES, 26 X 31MM AT THE DISSECTION 2CM BELOW THE RENAL ARTERIES, NARROWS AGAIN 4CM BELOW THE RENAL ARTERIES (19 X 27MM) AT THE DISTAL END OF THE PROXIMAL NECK, BEFORE EXPANDING INTO THE 5CM ABDOMINAL AORTIC ANEURYSM. THE DISTAL AORTIC DIAMETER MEASURED 19MM. A VIDEO OF THE ANGIOGRAM AT IMPLANT SHOWS AN ENDOLEAK, COMING FROM NEAR THE FLOW DIVIDER (OF BOTH THE BIFURCATE AND CONTRA LIMB), ON THE LEFT/CONTRA SIDE. THIS AREA IS ALSO LOCATED NEAR THE PROTRUDING STENT, WHICH APPEARS TO BE JUST BELOW THE NARROWED DISTAL SHELF OF THE PROXIMAL NECK WHERE THE AAA STARTS. THE ENDOLEAK MAY BE A TYPE III FABRIC, BUT CANNOT RULE OUT A TYPE IV. ALSO NOTED THAT THE CONTRALATERAL LIMB WAS OVERLAPPING THE GATE 1.5CM HIGHER THAN THE RECOMMENDED MARKERS. IMAGES AFTER RELINING THE LIMBS WERE NOT PROVIDED. THE CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201751 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03025028

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR