BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE VIABAHN ENDOPROSTHESIS - 3

    MDR report key: 10125114 · Received June 5, 2020

    Report

    Report Number
    2017233-2020-00405
    Event Type
    Death
    Date Received
    June 5, 2020
    Date of Event
    April 21, 2020
    Report Date
    July 21, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B.5. UPDATED MEDWATCH WAS SENT IN ERROR. ADDITIONAL RECEIVED INFORMATION DETERMINED THAT THIS EVENT IS NOT REPORTABLE TO THE FDA AND THEREFORE THE MEDWATCH IS BEING RETRACTED.

    Additional Manufacturer Narrative · 0

    H.6. CONCLUSION CODE 1 UPDATED.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: IN AN ARTICLE TITLED EARLY OUTCOMES OF NATIVE AND GRAFT RELATED ABDOMINAL AORTIC INFECTION MANAGED WITH ORTHOTOPIC XENOPERICARDIAL GRAFTS IT STATES BETWEEN JULY 2017 AND SEPTEMBER 2019, PATIENTS WITH NATIVE AND GRAFT RELATED ABDOMINAL AORTIC INFECTION, WHO UNDERWENT ABDOMINAL AORTIC REPLACEMENT WITH XENOPERICARDIAL GRAFT WERE INCLUDED IN THE STUDY. RUPTURED INFECTED AORTAS WERE EXCLUDED. A RETROSPECTIVE ANALYSIS WAS PERFORMED USING A PROSPECTIVELY MAINTAINED DATABASE. PATIENT # 12 UNDERWENT AN AORTO BIFEMORAL BYPASS FOR AORTO-ILIAC ANEURYSMS WITH A XENOPERICARDIAL AORTIC GRAFT. AT 2 MONTHS HE PRESENTED WITH A SYMPTOMATIC FALSE ANEURYSM OF A DISTAL ILIAC ANASTOMOSIS (PAIN AND ANEMIA), WITHOUT ANY CLINICAL SIGNS OF INFECTION, AND NEGATIVE MICROBIOLOGY. ENDOVASCULAR EXCLUSION WITH A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE COMBINED WITH SURGICAL EVACUATION OF THE HEMATOMA WAS PERFORMED. THE ARTICLE STATED AT 5 MONTHS, THE VIABAHN ENDOGRAFT WAS MANIFESTING SIGNS OF INFECTION. THE AUTHOR LATER STATED THE PATIENT DID NOT HAVE AN INFECTED ENDOGRAFT, BUT RATHER ABDOMINAL SEPSIS. CULTURES WERE POSITIVE FOR ESCHERICHIA COLI. ANTIOBIOTICS: IMIPENEM, AMIKACIN AND DAPTOMYCIN WERE STARTED. THREE DAYS AFTER ANTIBIOTIC THERAPY WAS STARTED, THE ENDOGRAFT WAS EXPLANTED PREVENTIVELY AND RECONSTRUCTED WITH FEMORO-FEMORAL ARTERIAL ALLOGRAFT. THE PATIENT DIED IN CRITICAL CARE FROM MULTI ORGAN FAILURE. THE AUTHOR STATED THERE WAS NO RELATIONSHIP BETWEEN THE INFECTION AND THE VIABAHN DEVICE. LITERATURE CITATION: ALONSO W, OZDEMIR B, CHASSIN-TRUBERT L, ZIZA V, ALRIC P, CANAUD L, EARLY OUTCOMES OF NATIVE AND GRAFT RELATED ABDOMINAL AORTIC INFECTION MANAGED WITH ORTHOTOPIC XENOPERICARDIAL GRAFTS, JOURNAL OF VASCULAR SURGERY (2020), DOI: HTTPS://DOI.ORG/10.1016/J.JVS.2020.04.513.

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: ALONSO W, OZDEMIR B, CHASSIN-TRUBERT L, ZIZA V, ALRIC P, CANAUD L, EARLY OUTCOMES OF NATIVE AND GRAFT RELATED ABDOMINAL AORTIC INFECTION MANAGED WITH ORTHOTOPIC XENOPERICARDIAL GRAFTS, JOURNAL OF VASCULAR SURGERY (2020), DOI: HTTPS://DOI.ORG/10.1016/J.JVS.2020.04.513.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: IN AN ARTICLE TITLED EARLY OUTCOMES OF NATIVE AND GRAFT RELATED ABDOMINAL AORTIC INFECTION MANAGED WITH ORTHOTOPIC XENOPERICARDIAL GRAFTS IT STATES BETWEEN JULY 2017 AND SEPTEMBER 2019, PATIENTS WITH NATIVE AND GRAFT RELATED ABDOMINAL AORTIC INFECTION, WHO UNDERWENT ABDOMINAL AORTIC REPLACEMENT WITH XENOPERICARDIAL GRAFT WERE INCLUDED IN THE STUDY. RUPTURED INFECTED AORTAS WERE EXCLUDED. A RETROSPECTIVE ANALYSIS WAS PERFORMED USING A PROSPECTIVELY MAINTAINED DATABASE. PATIENT # 12 UNDERWENT AN AORTO BIFEMORAL BYPASS FOR AORTO-ILIAC ANEURYSMS WITH A XENOPERICARDIAL AORTIC GRAFT. AT 2 MONTHS HE PRESENTED WITH A SYMPTOMATIC FALSE ANEURYSM OF A DISTAL ILIAC ANASTOMOSIS (PAIN AND ANEMIA), WITHOUT ANY CLINICAL SIGNS OF INFECTION, AND NEGATIVE MICROBIOLOGY. ENDOVASCULAR EXCLUSION WITH A GORE® VIABAHN® ENDOPROSTHESIS COMBINED WITH SURGICAL EVACUATION OF THE HEMATOMA WAS PERFORMED. AT 5 MONTHS, THE VIABAHN ENDOGRAFT WAS MANIFESTING SIGNS OF INFECTION. CULTURES WERE POSITIVE FOR ESCHERICHIA COLI. ANTIOBIOTICS: IMIPENEM, AMIKACIN AND DAPTOMYCIN WERE STARTED. THREE DAYS AFTER ANTIBIOTIC THERAPY WAS STARTED, THE ENDOGRAFT WAS EXPLANTED AND RECONSTRUCTED WITH FEMORO-FEMORAL ARTERIAL ALLOGRAFT. THE PATIENT DIED IN CRITICAL CARE FROM MULTI ORGAN FAILURE. LITERATURE CITATION: ALONSO W, OZDEMIR B, CHASSIN-TRUBERT L, ZIZA V, ALRIC P, CANAUD L, EARLY OUTCOMES OF NATIVE AND GRAFT RELATED ABDOMINAL AORTIC INFECTION MANAGED WITH ORTHOTOPIC XENOPERICARDIAL GRAFTS, JOURNAL OF VASCULAR SURGERY (2020), DOI: HTTPS://DOI.ORG/10.1016/J.JVS.2020.04.513.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588733 GORE VIABAHN ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death