BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 2884005 · Received December 21, 2012

    Report

    Report Number
    2953200-2012-02471
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    January 9, 2013
    Report Date
    February 7, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (FISTULA). (UNKNOWN CAUSE). CONCLUSION: OTHER (UNKNOWN CAUSE).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.7 CM IN DIAMETER ANEURYSM WAS REPORTED WITH AN INFRA-RENAL ANGLE OF 30 DEGREES. PROXIMAL AORTA WAS 25 MM IN DIAMETER AND 27 MM IN LENGTH. RIGHT ILIAC ARTERY WAS 9 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 19 MM IN DIAMETER. THE RIGHT AND LEFT FEMORAL ARTERIES WERE 13 MM IN DIAMETER. THERE WAS A TYPE II ENDOLEAK, WHICH WAS LEFT UNCORRECTED. IT WAS REPORTED THAT AT THE ONE MONTH FOLLOW-UP, THE PATIENT PRESENTED WITH A LYMPH FISTULA. THE INVESTIGATOR ASSESSED THIS EVENT TO BE RELATED TO THE PROCEDURE AND NOT TO THE DEVICE. THE PATIENT WAS GIVEN MEDICATION AND THE EVENT RESOLVED. THE PHYSICIAN WILL MONITOR THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW OF THIS FILE REVELED THAT THERE WAS LYMPHORRHEA OF LEFT SCARPA ASSOCIATED WITH THE LYMPH FISTULA WHICH NECESSITATED LOCAL CARE FOR THREE WEEKS. IT WAS ALSO NOTED THAT THERE WAS NO SEPTIC PROBLEM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: A CT WITH CONTRAST APPROXIMATELY THREE WEEKS AGO REVEALED PARTIAL THROMBUS OF THE LEFT LEG AND THE PATIENT WAS PRESCRIBED A LONG-TERM ORAL ANTICOAGULATION TREATMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: THE CONTRALATERAL LIMB 162480 AND CONTRALATERAL EXTENSION 202080 WERE IMPLANTED ON THE LEFT SIDE WHILE THE BIFURCATED STENT GRAFT WAS IMPLANTED ON THE RIGHT SIDE. THE THROMBOSIS WAS LOCATED WITHIN THE 2820145 AND THE 162480 STENT GRAFTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01090385

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention