BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 15899393 · Received December 1, 2022

    Report

    Report Number
    2017233-2022-03526
    Event Type
    Injury
    Date Received
    December 1, 2022
    Date of Event
    July 22, 2022
    Report Date
    December 1, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE LOT/SERIAL INFORMATION COULD NOT BE OBTAINED. THEREFORE, NO MANUFACTURING EVALUATION COULD BE PERFORMED. NO INFORMATION ABOUT THE DEVICE AVAILABILITY. CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. CAUSE OF THE REPORTED EVENT CANNOT BE ESTABLISHED BASED ON THE INFORMATION REPORTED TO GORE. FURTHER INFORMATION REGARDING THIS EVENT WAS REQUESTED BY GORE, BUT NO FURTHER INFORMATION HAS BEEN REPORTED, THEREFORE THIS INVESTIGATION IS CONSIDERED COMPLETE. CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    THE FOLLOWING PUBLICATION WAS REVIEWED BY GORE: TITLE: ENDOVASCULAR HEMOSTASIS USING VIABAHN FOR INTRA-ABDOMINAL BLEEDING AND PSEUDOANEURYSM AFTER PANCREATIC SURGERY IN OUR HOSPITAL SOURCE: OFFICIAL JOURNAL OF JAPANESE SOCIETY OF GASTROENTEROLOGICAL SURGERY 2022: 77 P.RS19-2 WE REVIEWED THE OUTCOMES OF ENDOVASCULAR HEMOSTASIS USING GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN) FOR INTRA-ABDOMINAL HEMORRHAGE/PSEUDOANEURYSM (PPH) AFTER PANCREATECTOMY AT OUR SITE. OF 555 PANCREATECTOMIES PERFORMED BETWEEN 2012 AND 2020, 31 CASES THAT RESULTED IN PPH WERE COMPARED IN TERMS OF HEMOSTATIC SITE, TREATMENT OUTCOME, AND ADVERSE EVENTS BETWEEN CASES WITH IMPLANTED VIABAHN AND THOSE WITH TRANSCATHETER ARTERIAL EMBOLIZATION (TAE). 8 PATIENTS (26%) UNDERWENT VIABAHN IMPLANTATION, 18 (58%) UNDERWENT TAE, AND 5 (16%) UNDERWENT A COMBINATION OF VIABAHN AND TAE. THE SITE OF THE VIABAHN WAS THE MAIN ARTERY (COMMON HEPATIC ARTERY/INTRINSIC HEPATIC ARTERY/SUPERIOR MESENTERIC ARTERY/UMBILICAL ARTERY) IN 11 PATIENTS (85%), THE PRIMARY BRANCH (GASTRODUODENAL ARTERY/RIGHT AND LEFT HEPATIC ARTERY) IN 2 PATIENTS (15%), AND THE PERIPHERAL ARTERY (RIGHT GASTRODUODENAL ARTERY/ DORSAL PANCREATIC ARTERY ETC.) IN 0 PATIENTS (0%). THE MEDIAN TIME TO HEMOSTASIS FOR PATIENTS AFTER 2016 WAS 113.5 MINUTES (69-188 MINUTES) FOR VIABAHN/TAE AND 111.5 MINUTES (111.5 MINUTES) FOR VIABAHN/TAE, RESPECTIVELY. MINUTES) / 111.5 MINUTES (50-180 MINUTES) FOR VIABAHN/TAE, RESPECTIVELY, WITH NO SIGNIFICANT DIFFERENCE. AS ADVERSE EVENTS ASSOCIATED WITH HEMOSTATIC PROCEDURES, HIGH LIVER ENZYMES VALUE ON THE NEXT DAY OF THE PROCEDURE WERE OBSERVED IN 1 PATIENT (8%) AFTER VIABAHN IMPLANTATION AND 4 PATIENTS (17%) AFTER TAE, WITH NO SIGNIFICANT DIFFERENCE BETWEEN THE TWO GROUPS (P=0.395. OF THE 13 PATIENTS WITH VIABAHN IMPLANTATION, 6 PATIENTS (46%) AND 9 PATIENTS (46%) RECEIVED CONTINUOUS HEPARIN, ANTIPLATELET AGENTS AND ANTICOAGULANTS, RESPECTIVELY, AFTER HEMOSTASIS. 46%)/9 (69%), RESPECTIVELY, OF WHICH 3/3 HAD BLEEDING ADVERSE EVENTS. ON THE OTHER HAND, NONE OF THE TAE PATIENTS RECEIVED ANTIPLATELET/ANTICOAGULANT DRUGS AFTER HEMOSTATIC TREATMENT. PERIOPERATIVE MORTALITY WAS 2 (25%)/2 (11%)/1 (20%) IN THE VIABAHN/TAE/VIABAHN + TAE GROUPS, RESPECTIVELY, WITH NO SIGNIFICANT DIFFERENCE. THE MEDIAN OBSERVATION PERIOD AFTER VIABAHN IMPLANTATION WAS 9.7 MONTHS (0.3-55.5 MONTHS), AND STENT STENOSIS/OCCLUSION WAS OBSERVED IN 2 PATIENTS. ALTHOUGH THE VIABAHN IMPLANTATION PROVIDED HEMOSTASIS FOR PPH WHILE MAINTAINING PATENCY OF THE MAIN ARTERY, IT REQUIRED POSTOPERATIVE ANTICOAGULATION/ANTIPLATELET THERAPY, WHICH SIGNIFICANTLY INCREASED BLEEDING COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2398649 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| H