BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2943908 · Received February 5, 2013

    Report

    Report Number
    2953200-2013-00188
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    July 2, 2010
    Report Date
    April 4, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: (FILMS).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSION: (ENDOLEAK). (UNKNOWN CAUSE AND LOCATION OF ENDOLEAK).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN UNSCHEDULED VISIT APPROXIMATELY 10 MONTHS POST IMPLANT AFTER IMAGING WAS PERFORMED A MONTH BEFORE. THE IMAGING HAD REVEALED AN UNKNOWN ENDOLEAK WAS PRESENT.

    Description of Event or Problem · 1

    FILMS WERE RECEIVED AND THEIR EVALUATION WAS COMPLETED. ULTRASOUND IMAGES FROM THE FOLLOW-UP STUDIES COULD NOT CONFIRM OR RULE OUT THE REPORTED POSSIBLE ENDOLEAK. NO OBVIOUS STENT GRAFT INTEGRITY ISSUES WERE OBSERVED. THE LOCATION OF THE POSSIBLE ENDOLEAK WAS NOT PROVIDED, AND CTA'S WERE NOT PROVIDED TO ASSIST WITH THE VISUALIZATION AND CAUSE OF ANY POSSIBLE ENDOLEAK.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 4.4 CM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 40 MONTHS AGO WITH AN INFRA-RENAL NECK ANGLE OF 45 DEGREES. THE LEFT ILIAC ANEURYSM WAS 60 MM IN DIAMETER, AND THE RIGHT ILIAC ANEURYSM WAS 25 MM IN DIAMETER. THE AORTIC NECK WAS 24.8 - 25 MM IN DIAMETER AND 21 MM IN LENGTH. THE DISTAL AORTA WAS 41 MM IN DIAMETER. THE DIAMETER OF THE RIGHT ILIAC ARTERY WAS 24.3 MM. THE FEMORAL ARTERIES WERE 10 MM IN DIAMETER BILATERALLY AND THEY WERE MILDLY TORTUOUS WITH NO STENOSIS. THE CIRCUMFERENTIAL AORTIC MURAL THROMBUS/CALCIFICATION AT THE PROXIMAL NECK WAS 10%. IT WAS REPORTED THAT A ROUTINE FOLLOW-UP ULTRASOUND 33 MONTHS POST IMPLANT SHOWED POSSIBLE MINIMAL ENDOLEAKS. AN ULTRASOUND DONE 11 MONTHS LATER ALSO SHOWED POSSIBLE MINIMAL ENDOLEAKS. THE LOCATION OF THE ENDOLEAKS WAS NOT REPORTED. NO INTERVENTION WAS PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49320 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00343343

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR