BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® HYBRID VASCULAR GRAFT

    MDR report key: 3880413 · Received June 18, 2014

    Report

    Report Number
    2017233-2014-00321
    Event Type
    Death
    Date Received
    June 18, 2014
    Date of Event
    May 25, 2014
    Report Date
    May 25, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K093934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASED SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT WAS TREATED FOR AN AORTIC DEBRANCHING PROCEDURE WHERE FOUR GORE® HYBRID VASCULAR GRAFTS WERE USED. A CTA MEASUREMENT WAS PERFORMED OF THE CELIAC TRUNK, THE TWO RENAL ARTERIES AND THE SUPERIOR MESENTERIC ARTERY IN ORDER TO TREAT A SYMPTOMATIC MYCOTIC ANEURYSM LOCALIZED ON THE DESCENDING AORTA TO THE DISTAL ABDOMINAL AORTA. THE FOUR GORE® HYBRID VASCULAR GRAFTS WERE SUTURED ON A DACRON PROSTHESIS. THE PATIENT PRESENTED WITH AN INFECTION FROM THE MYCOTIC ANEURYSM. THE MEDICAL DEVICE WAS FLUSHED WITH THE PATIENT¿S BLOOD AND A THORACIC LAPAROTOMY PROCEDURE WAS PERFORMED. THE ISCHEMIC TIME FOR ALL VISCERAL ARTERIES WAS 26 MINUTES. IT WAS REPORTED TO GORE THAT THROMBOSIS WAS OBSERVED IN THE LEFT RENAL ARTERY AFTER IMPLANTING THE MEDICAL DEVICE. IT WAS STATED THAT THE GRAFT PORTION OF THE HYBRID APPEARED COMPRESSED AT THE END OF THE STENT AND WAS PRESSING AGAINST THE BIFURCATION. THROMBECTOMY PROCEDURES WERE PERFORMED ON ALL FOUR GORE® HYBRID VASCULAR GRAFTS. IT WAS STATED THAT THE LEFT RENAL ARTERY TURNED ISCHEMIC. THE GORE® HYBRID VASCULAR GRAFT IN THE LEFT RENAL ARTERY WAS EXPLANTED AND A CLASSICAL BYPASS WAS PERFORMED WITH THE REMAINING UNUSED PORTION OF THE VASCULAR GRAFT FROM THE GORE® HYBRID VASCULAR GRAFT. DURING THE PROCEDURE, ALL THE ORGAN FUNCTIONS, EXCEPT FOR THE LEFT RENAL ARTERY, WERE GOOD. LESS URINE WAS PRODUCED THAN EXPECTED. GOOD CIRCULATION WAS REPORTED. THE PATIENT WAS CLOSED FROM THE PROCEDURE. DUE TO INTERNAL BLEEDING FROM THE SPLEEN, HEPARIN WAS NOT ADMINISTERED DURING OR AFTER THE PROCEDURE. THE PATIENT LOST APPROXIMATELY 3 LITERS OF BLOOD DURING THE PROCEDURE. ON (B)(6) 2014, THE PATIENT COLLAPSED AND WAS IN DECLINING HEALTH. THE THREE IMPLANTED GORE® HYBRID VASCULAR GRAFTS AND THE BYPASS GRAFT WERE ALL OCCLUDED. THE BOWEL, SMALL INTESTINES, LIVER AND SPLEEN WERE ALL NECROTIC. THROMBECTOMIES OF THE MEDICAL DEVICES AND VESSELS WERE PERFORMED. THE PROXIMAL ENDS OF THE GRAFTS WERE SHORTENED DUE TO A SLIGHT ROTATION OF THE DACRON GRAFT. ON (B)(6) 2014, IT WAS REPORTED TO GORE THAT THE PATIENT EXPIRED AFTER ANOTHER LAPAROSCOPIC SURGERY AND A COLLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357911 GORE® HYBRID VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 11530227

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death 05/23/2014 DACRON PROSTHESIS AND 3 GORE® GRAFTS.