BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3646933 · Received February 26, 2014

    Report

    Report Number
    2953200-2014-00332
    Event Type
    Injury
    Date Received
    February 26, 2014
    Date of Event
    November 25, 2013
    Report Date
    February 3, 2014
    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). EVALUATION, RESULTS: PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PERIAORTIC FIBROSIS), INHERENT RISK OF PROCEDURE (RENAL FAILURE), (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN); EVALUATION, CONCLUSIONS: DEVICE FAILURE RELATED TO PATIENT CONDITION (PERIAORTIC FIBROSIS), KNOWN INHERENT RISK OF A PROCEDURE (RENAL FAILURE), (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. DE NOVO PERIAORTIC FIBROSIS AFTER ENDOVASCULAR AORTIC REPAIR, ANN VASC SURG 2014; 28: 493.E1¿493.E3 FARIS ALOMRAN, ROMAIN DE BLIC, ALEXANDROS MALLIOS, ALESSANDRO COSTANZO, BENOIT BOURA AND MYRIAM COMBES. (ANN VASC SURG 2014; 28: 49 3.E1¿493.E3). HTTP://DX.DOI.ORG/10.1016/J.AVSG.2013.06.019. A (B)(6) MAN PRESENTED WITH A NON-INFLAMMATORY, 51-MM ABDOMINAL AORTIC ANEURYSM. STANDARD PREOPERATIVE WORK-UP WAS UNREMARKABLE, SHOWING A LEUKOCYTE COUNT OF 7700 MM3 AND A C-REACTIVE PROTEIN (CRP) OF 8 MG/L. THE PATIENT UNDERWENT CONVENTIONAL EVAR WITH A BIFURCATED GRAFT. POSTOPERATIVELY, HE WAS WELL BEYOND A 24-HR PERIOD OF HYPERTHERMIA THAT OCCURRED, WHICH SPONTANEOUSLY RESOLVED WITHOUT TREATMENT. THE HYPERTHERMIA WAS ATTRIBUTED TO POSTIMPLANTATION SYNDROME AND THE PATIENT WAS DISCHARGED ON DAY 5 AS PER PROTOCOL AFTER A SATISFACTORY COMPUTED TOMOGRAPHY (CT) SCAN SHOWING NO EVIDENCE OF PERIAORTITIS, ENDOLEAK, OR DEVICE MIGRATION. IT WAS REPORTED THAT ON AN UNKNOWN DATE, AT A 3-MONTH FOLLOW-UP, THE PATIENT COMPLAINED OF VAGUE ABDOMINAL DISCOMFORT AND CONSTIPATION. WORK-UP INCLUDED A STANDARD BLOOD PANEL, COLONOSCOPY, AND A CT SCAN, ALL OF WHICH WERE UNREMARKABLE. AT 8 MONTHS POSTOPERATIVELY, THE PATIENT UNDERWENT A STANDARD BLOOD TEST THAT REVEALED ACUTE-ONSET RENAL FAILURE WITH A SERUM CREATININE OF 124 MMOL/L AND AN INFLAMMATORY SYNDROME WITH A CRP OF 124 MG/L. AT THIS STAGE, CT IMAGING REVEALED PERIAORTIC FIBROSIS ENGULFING THE URETERS CAUSING HYDRONEPHROSIS, BUT NO GRAFT ABNOR MALITIES. THE PATIENT WAS URGENTLY HOSPITALIZED AND UNDERWENT URETER DRAINAGE BY PLACEMENT OF DOUBLE J CATHETERS IN BOTH URETERS. PREDNISOLONE THERAPY WAS INITIATED AT 1 MG/KG AND REDUCED BY 5 MG BIMONTHLY. THERE WAS AN IMMEDIATE REDUCTION IN BIOLOGIC INFLAMMATORY MARKERS AND RENAL FUNCTION RETURNED TO BASELINE 2 WEEKS LATER. CT SCAN 3 MONTHS AFTER COMMENCEMENT OF STEROIDAL THERAPY REVEALED A SIGNIFICANT REDUCTION IN PERIAORTIC FIBROSIS AND CORRECT PLACEMENT OF BOTH DOUBLE J CATHETERS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE AUTHORS CONCLUDE THAT PAF POST-EVAR REMAINS A VERY RARE COMPLICATION. THE PATHOPHYSIOLOGY MAY BE SUGGESTIVE OF A PROGRESSION OF PIS POST-EVAR INTO PAF, BUT THERE IS LITTLE EVIDENCE TO SUPPORT THIS CLAIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119209 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention