BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® PROPATEN® VASCULAR GRAFT

    MDR report key: 20789557 · Received November 26, 2024

    Report

    Report Number
    2017233-2024-05544
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    July 1, 2024
    Report Date
    November 27, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: EIGHT CASES OF NEW ARTIFICIAL VASCULAR BYPASS WITH PRESERVATION OF THE ARTIFICIAL VASCULAR OUTFLOW TRACT STENT GRAFT (VIABAHN) SOURCE: KIDNEY AND DIALYSIS 2024: VOLUME 96 SPECIAL EDITION RENAL FAILURE SURGERY AND INFECTIOUS DISEASES P.44-48. A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. H6: CODE D12: ACCORDING TO THE GORE® PROPATEN® VASCULAR GRAFT INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: MECHANICAL DISRUPTION OR TEARING OF THE SUTURE LINE, GRAFT, AND / OR HOST VESSEL. 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: EIGHT CASES OF NEW ARTIFICIAL VASCULAR BYPASS WITH PRESERVATION OF THE ARTIFICIAL VASCULAR OUTFLOW TRACT STENT GRAFT (VIABAHN) SOURCE: KIDNEY AND DIALYSIS 2024: VOLUME 96 SPECIAL EDITION RENAL FAILURE SURGERY AND INFECTIOUS DISEASES P.44-48. IN OUR HOSPITAL, WE HAVE OBSERVED EIGHT CASES IN WHICH A NEW ARTIFICIAL BLOOD VESSEL BYPASS WAS PERFORMED WHILE PRESERVING THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN) DUE TO PROBLEMS AT THE PUNCTURE SITE, SUCH AS INFECTION OR DETERIORATION, AFTER PLACEMENT OF VIABAHN IN THE ARTIFICIAL BLOOD VESSEL OUTFLOW TRACT. THE MEAN AGE WAS 71.6± 13.2 YEARS (RANGE 47-88 YEARS), WITH 4 MALES AND 4 FEMALES. THE INTERVAL FROM GRAFT IMPLANT TO VIABAHN PLACEMENT WAS 426.8 ± 260.6 DAYS (RANGE 54-736 DAYS). THE INTERVAL FROM VIABAHN PLACEMENT TO CREATION OF A NEW VIABAHN-PRESERVATION BYPASS WAS 268.6 ± 187.7 DAYS (RANGE 17-509 DAYS). THE MEAN FOLLOW-UP PERIOD WAS 329.3 ± 88.1 DAYS (RANGE 172-394 DAYS). AS SHOWN IN TABLE 1, GORE® PROPATEN ® VASCULAR GRAFT (PROPATEN) OR GORE® ACUSEAL VASCULAR GRAFT (ACUSEAL) WERE PLACED IN ALL PATIENTS. AFTER VIABAHN PLACEMENT, THE ENTIRE PUNCTURE AREA NEEDED TO BE REMOVED DUE TO THE SPREAD OF INFECTION AT THE PUNCTURE SITE (2 CASES OF PROPATEN), OR THE ARTIFICIAL VASCULAR GRAFT MAINLY AT THE PUNCTURE SITE WAS DEGRADED, MAKING PUNCTURE DIFFICULT OR PRONE TO OCCLUSION (4 CASES OF PROPATEN, 2 CASES OF ACUSEAL), LEADING TO NEW BYPASS SURGERY. IN ALL CASES, THE VIABAHN WAS WELL PATENT, AND IT WAS JUDGED POSSIBLE TO PERFORM A CONSERVATIVE BYPASS AS AN OUTFLOW TRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850278 GORE® PROPATEN® VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown Required Intervention