BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 21639077 · Received March 18, 2025

    Report

    Report Number
    2017233-2025-05952
    Event Type
    Injury
    Date Received
    March 18, 2025
    Date of Event
    October 29, 2024
    Report Date
    April 10, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. DUE TO AN UNKNOWN LOT/SERIAL NUMBER AND NO DEVICE RETURN, AN INVESTIGATION COULD NOT BE PERFORMED. CITE THIS ARTICLE XIAOYE LI, SHIBO XIA, LIANGXI YUAN, LEI ZHANG, CHAO SONG, XIAOLONG WEI, QINGSHENG LU, STENT-GRAFT IMPLANTATION FOR LATE POSTPANCREATECTOMY HEMORRHAGE AFTER PANCREATODUODENECTOMY, CHINESE JOURNAL OF TRAUMATOLOGY, VOLUME 28, ISSUE 1, 2025, PAGES 7-12, ISSN 1008-1275, HTTPS://DOI.ORG/10.1016/J.CJTEE.2024.08.009. 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.

    Additional Manufacturer Narrative · 0

    OPEN BY ERROR, NO ADDITIONAL UPDATE NEEDED.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS RECEIVED THROUGH LITERATURE ¿STENT-GRAFT IMPLANTATION FOR LATE POSTPANCREATECTOMY HEMORRHAGE AFTER PANCREATODUODENECTOMY¿, CHIN J TRAUMATOL. 2025;28(1):7-12. DOI:10.1016/J.CJTEE.2024.08.009. THIS WAS A SINGLE-CENTER, RETROSPECTIVE STUDY OF PATIENTS WITH PANCREATIC CANCER THAT UNDERWENT PANCREATODUODENECTOMY AND THEN HAD POST PANCREATECTOMY HEMORRHAGE [PPH]. OF THOSE PATIENTS, 16 UNDERWENT ENDOVASCULAR INTERVENTION OWNING TO LATE PPH, INCLUDING 4 CASES TREATED WITH TRANSARTERIAL EMBOLIZATION [TAE] AND 12 CASES [9 MALE AND 3 FEMALE, AGES 44-80] TREATED WITH SELF-EXPANDING COVERED STENT-GRAFT IMPLANTATION. ALL 12 CASES USED SELF-EXPANDABLE COVERED STENT-GRAFT VIABAHN [5-8 MM DIAMETER]. TECHNICAL SUCCESS WAS ACHIEVED IN ALL CASES. IN ONE CASE, POST-STENT BALLOON DILATION WAS REQUIRED, IN 3 CASES, 2 VIABAHN WERE IMPLANTED, IN 2 CASES, PULSAR STENT-GRAFT WAS DEPLOYED DISTAL TO THE VIABAHN WITH SEVERAL SEGMENTS OVERLAPPING DUE TO LACK OF VIABAHN APPROPRIATE SIZE. BLEEDING WAS CONTROLLED AND DISTAL ORGAN PERFUSION REMAINED PATIENT. TWO CASES OF ASYMPTOMATIC STENT-GRAFT OCCLUSION WERE OBSERVED AT 24.6 AND 26.3 AFTER THE OPERATION, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211619 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other