BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3177830 · Received June 19, 2013

    Report

    Report Number
    2953200-2013-01159
    Event Type
    Injury
    Date Received
    June 19, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (UNKNOWN CAUSE OF EVENT). CONCLUSION: (UNKNOWN CAUSE OF EVENT).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THE PROCEDURE WENT WELL; HOWEVER, THERE WAS A HEMATOMA AND THE PATIENT LOST A LOT OF BLOOD. THE PATIENT HAD TEMPORARY PARALYSIS WHICH WAS THOUGHT TO BE RELATED TO THE HEMATOMA. AN MRI WAS PERFORMED TO DETERMINE IF THE PARALYSIS WAS CAUSED BY THE HEMATOMA IN ORDER TO DECIDE WHETHER TO PERFORM AN OPEN REPAIR PROCEDURE. IT WAS REPORTED THAT A SPINAL DRAIN WAS PERFORMED AND THAT RESOLVED THE PARALYSIS. IT WAS REPORTED THAT EIGHTEEN MONTHS POST INDEX PROCEDURE THE DEVICE HAS MIGRATED 10 MM, AND THE ANEURYSM WAS 64 IN DIAMETER AND 45 IN LENGTH. TWO YEARS LATER, THE DEVICE HAD MIGRATED 3 CM, THE AORTIC NECK WAS 24-30 MM IN DIAMETER AND THE ANEURYSM WAS 61 IN DIAMETER AND 56 IN LENGTH. THE FOLLOWING YEAR, THE ANEURYSM WAS 62 IN DIAMETER AND 64 IN LENGTH. CURRENTLY, THERE IS A BIG PROXIMAL TYPE I ENDOLEAK AND THE DEVICE HAS MIGRATED 4.3-5 CM FROM THE RENAL ARTERIES AND THE NECK IS DILATED. ALSO, THERE IS A DISTAL ILIAC DILATION OR ENLARGEMENT NEAR THE END OF THE STENT GRAFT; CAUSE OF THE EVENT IS UNKNOWN. THE PATIENT HAD A SECONDARY INTERVENTION TO TREAT THE MIGRATION AND THE PROXIMAL TYPE I ENDOLEAK. A 363670 AND A 363649 WERE SUCCESSFULLY IMPLANTED. A 202082 STENT GRAFT WAS ALSO IMPLANTED IN THE RIGHT COMMON ILIAC TO TREAT THE DISTAL ILIAC DILATION OR ENLARGEMENT NEAR THE END OF THE STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278776 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00001022

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention