BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT AAA STENT GRAFT SYSTEM

    MDR report key: 2853054 · Received November 30, 2012

    Report

    Report Number
    2953200-2012-02298
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    October 17, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (INFECTION). CONCLUSION: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: KANALIKOVA K JR, TOMKA J, NECPAL R, DULKA T, VULEV I, BAZIK R, BALAZ T, KUCEROVA D. KANALIKOVA K. TREATMENT OF STENTGRAFT INFECTION WITH FRESH-FROZEN ARTERIAL ALLOGRAFT, FOLLOWING ENDOVASCULAR AORTIC REPAIR FOR ABDOMINAL ANEURYSM OF AORTA. CARDIOLOGY LETTERS ( CARDIOL. LETT. ) ( SLOVAKIA ) JANUARY 1, 2012 , 21/5 (406-413) LANGUAGE: (B)(6). INTRODUCTION: INFECTION OF THE ABDOMINAL AORTIC ANEURYSM SAC IS A RARE CONDITION. ONLY A FEW DOCUMENTED CASES EXIST IN LITERATURE. THIS PRESENTATION DESCRIBES SOME TREATMENT OPTIONS BY WAY OF A COMPLEX CASE REPORT. CASE REPORT. THE AUTHORS PRESENT THE CASE OF A (B)(6) PATIENT WITH MANY CO-MORBIDITIES, IN WHOM AN INFRARENAL ANEURYSM OF THE ABDOMINAL AORTA HAD BEEN DIAGNOSED. THE PATIENT UNDERWENT IMPLANTATION OF A PERCUTANEOUS ENDOVASCULAR AORTIC DEVICE (ENDURANT STENTGRAFT SYSTEM) IN (B)(6) 2010. THE PROCEDURE WAS WITHOUT SERIOUS COMPLICATIONS. ABOUT SIX WEEKS LATER THE PATIENT PRESENTED WITH A SEPTIC FEBRILE STATE OF UNKNOWN ORIGIN. HE UNDERWENT A SERIES OF EXAMINATIONS, WHICH FINALLY UNCOVERED THE PRESENCE OF SPONDYLODISCITIS OF THE L2-L4 REGION, WITH PERIVERTEBRAL MICROABSCESSES AND INFECTION OF AN ANEURYSMATIC SAC. HEMOCULTURES SHOWED (B)(6) INFECTION. COMBINED WIDE-SPECTRUM ANTIBIOTIC THERAPY (LINEZOLID, MEROPENEM AND FLUCONAZOL) WAS THEN INITIATED. BECAUSE OF ITS INADEQUATE EFFECT, THE PATIENT WAS INDICATED FOR INTERVENTION. DURING SURGERY PARTIAL RESECTION OF THE INFECTED ANEURYSMATIC SAC WAS PROVIDED, FOLLOWED BY LAVAGE OF POUCH AND ABDOMINAL CAVITY. THE STENTGRAFT WAS COMPLETELY EXPLANTED AND A FRESH AORTIC ALLOGRAFT IN THE FORM OF AN AORTO-BIFEMORAL BYPASS WAS IMPLANTED. THE ORTHOPAEDIST (SPONDYLOSURGEON) PRESENT AT THE INTERVENTION ADVISED A CONSERVATIVE APPROACH (FINDINGS ON VERTEBRAL COLUMN). ANTIBIOTIC THERAPY CONTINUED AFTER SURGERY FOR 3 MONTHS (LATER CHANGED TO LINEZOLID ALONE) FOLLOWING THE ADVICE OF THE CLINICAL PHARMACOLOGIST AND ORTHOPAEDIST. FROM THE 7TH DAY FOLLOWING SURGERY LOW-DOSE IMMUNOSUPPRESSIVE THERAPY, USING TACROLIMUS, WAS INITIATED. GRADUALLY SIGNS OF THE INFLAMMATORY PROCESS DECLINED AND THE PATIENT BEGAN DOING WELL. IMAGING EXAMS SHOWED THE GOOD EFFECT OF RECONSTRUCTION. THERE WERE NO SIGNS OF GRAFT REJECTION. AFTER DISCHARGE HE WAS FOLLOWED-UP REGULARLY. HOWEVER, IN (B)(6) 2011, AT REGULAR OUT-PATIENT SURVEY, HE PRESENTED WITH SERIOUS PANCYTOPAENIA, WITH THE NEED FOR RE-ADMISSION FOR FURTHER INVESTIGATION. ACCORDING TO EXAMINATION, THE REASON FOR PANCYTOPAENIA WAS FOUND TO BE THE COMBINATION OF ANTIBIOTIC AND IMMUNOSUPPRESSION THERAPY. ADMINISTRATION OF ANTIBIOTICS TERMINATED. IT WAS SUCCEEDED BY IMPROVEMENT IN BLOOD SAMPLE TESTS. NO SIGN OF RECURRENCE OF THE INFLAMMATORY PROCESS HAS BEEN DETECTED. THE PATIENT IS REGULARLY EXAMINED IN OUR OUTPATIENT CLINIC, WITH NO FURTHER COMPLICATIONS TO TIME OF WRITING. DISCUSSION: THERE EXIST ONLY A FEW REPORTS OF THE USE OF FRESH (CRYOPRESERVED) ARTERIAL ABDOMINAL ALLOGRAFT IN THE TREATMENT OF PROSTHETIC GRAFT INFECTION. NEITHER IS THE NEED FOR FURTHER THERAPY YET WELL ESTABLISHED. WE TRIED USING THE FOLLOW-UP TREATMENT OPTIONS SUGGESTED IN SOME ARTICLES, EXPERIMENTAL WORKS ALREADY PUBLISHED, USING LOW-DOSE IMMUNOSUPPRESSION THERAPY IN THE LATE MANAGEMENT OF PATIENTS. FOR THE PRESENCE OF INFECTION, IT MAY BE EXPECTED THAT ANTIBIOTICS THERAPY IS NEEDED AS WELL. OUR CASE ALSO SHOWED THE POSSIBLE ADVERSE EFFECTS OF THIS UNUSUAL "COMBINED THERAPY". CONCLUSION: WITH THE INCREASING NUMBER OF ENDOVASCULAR AORTIC REPAIRS, WE MAY EXPECT SOME MORE, SIMILAR, COMPLICATIONS (EVEN THOUGH EXPECTED TO BE RARE). THIS CASE REPORT SHOWED SOME POSSIBLE TREATMENT. HOWEVER, OTHER INVESTIGATIONS AND REVIEWS ARE NEEDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention