BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3582330 · Received January 17, 2014

    Report

    Report Number
    2953200-2014-00082
    Event Type
    Injury
    Date Received
    January 17, 2014
    Date of Event
    December 27, 2013
    Report Date
    December 27, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS, CONCLUSIONS: INHERENT RISK OF PROCEDURE (ENDOLEAK); LACK OF INFORMATION (UNKNOWN CAUSE).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 58.3MM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE PROXIMAL NECK DIAMETER IS 21.8MM AND 23.6MM AT THE DISTAL END. THE PROXIMAL NECK LENGTH WAS 14.5MM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE A FINAL CT RUN NOTED A SUBSTANTIAL TYPE I ENDOLEAK. THE PHYSICIAN RE-BALLOONED AND SHOT RUNS TWO MORE TIMES; HOWEVER, THE ENDOLEAK CONTINUED. THE PHYSICIAN PULLED THE PIG BACK INSIDE THE BODY OF THE BIFURCATED GRAFT AND SHOT ANOTHER RUN. WITHOUT HAVING ANY CONTRAST ABOVE THE TOP OF THE GRAFT MATERIAL, THEY CONTINUED TO HAVE A SUBSTANTIAL ENDOLEAK INTO THE ANEURYSM. THE PHYSICIAN RE-BALLOON THE GATE EVEN THOUGH IT LOOKED LIKE IT WAS COMING FROM THE BODY OF THE GRAFT. THE PHYSICIAN DECIDED TO ADD ANOTHER GRAFT AND A 28X28X49 CUFF WAS IMPLANTED HOPING TO COVER THE DEFECT IN THE BODY OF THE GRAFT. THIS HELPED, BUT DID NOT RESOLVE THE TYPE IV ENDOLEAK. THERE WERE NO OTHER PROCEDURES PERFORMED. THE PHYSICIAN REPORTED THAT THE ENDOLEAK MIGHT RESOLVE ITSELF AFTER THE HEPARIN WEARS OFF. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN. REVIEWED SEVERAL RETURNED STILL ANGIO IMAGES AT IMPLANT. THE FIRST IMAGE SHOWS THAT THE BIFURCATE WAS IMPLANTED JUST BELOW THE RENAL ARTERIES; THERE IS MINIMAL L-R NECK ANGULATION SEEN. THERE IS A LARGE AREA OF CONTRAST SEEN IN THE AAA SAC, WHICH HAS THE APPEARANCE OF A TYPE IV BLUSH ENDOLEAK. THE LAST IMAGE SHOWS A POSSIBLE "JETTING" TYPE IV OR A TYPE III FABRIC ENDOLEAK NEAR THE FLOW DIVIDER. IMAGES POST CUFF IMPLANT WAS NOT PROVIDED. FROM THESE LIMITED IMAGES, THE TYPE AND CAUSE OF ENDOLEAK COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46016 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04134067

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention