BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT AUI

    MDR report key: 3073326 · Received April 23, 2013

    Report

    Report Number
    2953200-2013-00758
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 4, 2013
    Report Date
    September 24, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (RENAL INSUFFICIENCY, CONVERSION TO SURGICAL REPAIR). CONCLUSION: KNOWN INHERENT RISK OF A PROCEDURE (RENAL INSUFFICIENCY, CONVERSION TO SURGICAL REPAIR).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.6 CM IN DIAMETER INFRARENAL ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK WAS 23 MM IN DIAMETER AND 12 MM IN LENGTH. THE RIGHT ILIAC ARTERY WAS 8 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 13 MM IN DIAMETER. THE RIGHT AND LEFT FEMORAL ARTERIES WERE 8 MM IN DIAMETER. THERE WAS NO PRESENCE OF CIRCUMFERENTIAL THROMBUS OR CALCIFICATION. IT WAS REPORTED THAT THE PATIENT WAS IN FOR THEIR 6 MONTH FOLLOW UP APPOINTMENT AND A CT WITH CONTRAST SHOWED THAT THE ANEURYSM WAS 50 MM IN DIAMETER. THE PATIENT DEVELOPED SEPSIS AND WAS HOSPITALIZED AND TREATED. THEY SAW SOME PERI-AORTIC BUBBLES AROUND THE STENT GRAFT AND SUSPECTED CONNECTION BETWEEN DUODENUM AND AORTA THAT COULD EXPLAIN THIS SEPSIS. HOWEVER, IT IS STILL NOT CONFIRMED. PATIENT HAS BEEN SENT TO ANOTHER HOSPITAL FOR SURGERY. THE INVESTIGATOR ASSESSMENT HAS NOT BEEN COMPLETED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    THE DATE THAT THE DEVICE WAS EXPLANTED WAS RECEIVED. THE IMPLANTATION OF A DACRON PROSTHESIS IMPREGNATED BY SILVER BECAUSE VERY STRONG SUSPICION OF LOCALIZED INFECTION DUE TO DIGESTIVE CONTAMINATION WAS DONE. ALSO, THAT SAME DAY IT WAS REPORTED THAT THE PATIENT EXPERIENCED RENAL FAILURE AFTER THE SECONDARY INTERVENTION REQUIRING DIALYSIS. THE INVESTIGATOR ASSESSMENT STATES THAT THE EVENT IS NOT RELATED TO THE DEVICE OR THE PROCEDURE; HOWEVER IT IS RELATED TO THE ANEURYSM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN AORTO-DUODENAL FISTULA THAT WAS TREATED WITH THE PATIENT BEING SURGICALLY CONVERTED AND THE ENDURANT STENT GRAFT WAS EXPLANTED AND A SILVER SURGICAL GRAFT WAS IMPLANTED. THIS PROCEDURE HAS BEEN APPARENTLY COMPLICATED BY A RENAL INSUFFICIENCY/FAILURE. THE INVESTIGATOR ASSESSMENT STATES THAT THE EVENT IS NOT RELATED TO THE DEVICE OR THE PROCEDURE; HOWEVER IT IS RELATED TO THE ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173435 ENDURANT AUI SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00904167

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention