BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX ILIAC STENT GRAFT

    MDR report key: 2051282 · Received April 6, 2011

    Report

    Report Number
    2953200-2011-00777
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 11, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSION: (INFECTION). FILMS WERE RECEIVED AND THEIR EVALUATION IS AS FOLLOWS: THERE WERE AIR BUBBLES THAT MAY BE INDICATIVE OF THE INFECTION IN THE ARTERY COMMUNICATING DIRECTLY WITH THE ANEURYSM. IT IS SUSPECTED THAT THE INFECTION COULD HAVE BEGUN SOMEWHERE IN THE GI TRACT OR PROBABLY THE URINARY TRACT AND SUBSEQUENTLY MIGRATED INTRA-VASCULARLY TO THE ANEURYSM (THE ANEURYSM IS NOT WHERE THE INFECTION BEGAN). THE ANEURYSM INFECTION IS A SYMPTOM OF SOME OTHER DISEASE PROCESS THE PATIENT HAS DEVELOPED.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 11 CM ABDOMINAL AORTIC ANEURYSM OVER 8 YEARS AGO. VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WAS NOT REPORTED FIVE YEARS AND THREE MONTHS POST IMPLANT THERE WAS A PROXIMAL TYPE 1 ENDOLEAK (REF MFR # 2953200-2011-00773) AND BILATERAL DISTAL TYPE I ENDOLEAKS THAT WERE TREATED WITH ANOTHER MANUFACTURER'S STENT GRAFTS AT ANOTHER HOSPITAL (REF MFR# 2953200-2011-00774 AND 2953200-2011-00775). ON AN UNKNOWN DATE AND UNKNOWN REASON THERE WAS ALSO BARE METAL STENT PLACED IN THE LEFT EXTERNAL ILIAC ARTERY. IT WAS REPORTED THAT THE PATIENT PRESENTED ON (B)(6) 2011 TO THE EMERGENCY ROOM WITH SEVERE ABDOMINAL AND BACK PAIN AT A SMALL RURAL HOSPITAL, A CT AND ANGIOGRAM WERE PERFORMED AND THERE WAS ANEURYSM EXPANSION TO 12 CM IN DIAMETER, BUT NO EVIDENCE OF ENDOLEAK OR INFECTION AT THIS TIME. ON (B)(6) 2011, A SECOND CT AND ANGIOGRAM WERE PERFORMED. THE CT AND ANGIOGRAM REVEALED THAT THERE WAS AN INFECTION ON THE RIGHT LATERAL WALL OF THE ANEURYSM (THE INFECTION WAS NOT PRESENT ON THE CT ON (B)(6) 2011). IT WAS REPORTED THAT THE STENT GRAFT WAS EXPLANTED ON (B)(6) 2011. PRIOR TO PRESENTING AT THE EMERGENCY ROOM THE PATIENT HAD ABDOMINAL AND BACK PAIN FOR 8 DAYS. THE PATIENT HAD BLOOD WORK AND CULTURES DONE AND THEY CAME BACK AS POSITIVE FOR AN UNKNOWN INFECTION. THE PHYSICIAN ELECTED TO EXPLANT THE ENTIRE STENT GRAFT SYSTEM. THE 12 CM ANEURYSM WAS FOUND COMPLETELY FILLED WITH INFECTION. THE EXPLANTED STENT GRAFT WAS RETURNED AND ITS EVALUATION IS PENDING (REF MFR # 2953200-2011-00776). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX ILIAC STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA NA M02K550822

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention