BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3132433 · Received May 29, 2013

    Report

    Report Number
    2953200-2013-01009
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    June 5, 2013
    Report Date
    October 14, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    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). RESULTS: INHERENT RISK OF PROCEDURE (LYMPHOCELE/LYMPH FISTULA); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; FISTULA); (PROCEDURE RELATED). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; FISTULA); (PROCEDURE RELATED).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 5.5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE INFRA-RENAL ANGLE WAS REPORTED AS 50 DEGREES. PROXIMAL AORTA WAS 22-24 MM IN DIAMETER AND 32 MM IN LENGTH. RIGHT ILIAC ARTERY WAS 19 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 21 MM IN DIAMETER. THE RIGHT AND LEFT FEMORAL ARTERIES WERE 10 AND 11 MM IN DIAMETER, RESPECTIVELY. THERE WAS 40 PERCENT OF CIRCUMFERENTIAL THROMBUS OR CALCIFICATION. IT WAS REPORTED THAT LYMPHOCELE FISTULAS PRESENT AT BOTH SCARPAS AND PUNCTURE SITES BILATERALLY THAT RESOLVED TWO MONTHS POST IMPLANT. THE INVESTIGATOR ASSESSED THIS EVENT TO BE RELATED TO THE STUDY PROCEDURE BUT NOT THE STUDY DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. THE PHYSICIAN DOCUMENTED THAT THE LEFT SIDE LYMPHOCELE RESOLVED. HOWEVER, THERE WAS AN UPDATED THAT THERE WAS PERSISTENT LYMPHOCELE AT THE RIGHT SIDE OF A LIQUID MASS MEASURED TO 70 MM IN DIAMETER AND SHRANK TO 45 MM IN DIAMETER ONE MONTH LATER. THE INVESTIGATOR ASSESSED THIS EVENT TO BE RELATED TO THE STUDY PROCEDURE BUT NOT THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235825 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR V00887113

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR