BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® ACUSEAL VASCULAR GRAFT

    MDR report key: 15878606 · Received November 29, 2022

    Report

    Report Number
    2017233-2022-03516
    Event Type
    Injury
    Date Received
    November 29, 2022
    Date of Event
    November 9, 2022
    Report Date
    February 14, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    PMA / PMN Number
    K130215
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. TITLE: EXPERIENCE OF ACUSEAL AND TROUBLESHOOTING FOR MID-TO-LONG TERM FOLLOW-UP. SOURCE: JOURNAL OF JAPANESE SOCIETY FOR DIALYSIS THERAPY 2022: 55(SUPPL.1) P.618 PHYSICIAN: KYUICHI FURUHASHI. 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

    CORRECTED MEDICAL DEVICE PROBLEM CODE.

    Description of Event or Problem · 0

    THE FOLLOWING PUBLICATION WAS REVIEWED: TITLE: EXPERIENCE OF ACUSEAL AND TROUBLESHOOTING FOR MID-TO-LONG TERM FOLLOW-UP. SOURCE: JOURNAL OF JAPANESE SOCIETY FOR DIALYSIS THERAPY 2022: 55(SUPPL.1) P.618. THIS REPORT INCLUDES 6 CASES OF ACUSEAL IMPLANTATION IN ONE CLINIC SINCE 2017. THE PRIMARY PATENCY RATE WAS 83.3% AT 1 YEAR AND 50% AT 3 YEARS, AND THE SECONDARY PATENCY RATE WAS 100% AT BOTH 1 AND 3 YEARS. HEMATOMA FORMATION ASSOCIATED WITH WALL PENETRATION DUE TO EARLY PUNCTURE WAS OBSERVED DURING THE COURSE OF FOLLOW-UP SO THAT THE ULTRASOUND-GUIDED PUNCTURE WAS PERFORMED. AS MID-TO-LONG TERM COMPLICATIONS, THREE PATIENTS HAD VASCULAR STENOSIS DUE TO LOSS OF WALL MATERIAL FROM INTIMAL STRUCTURES OF GRAFTS. THE MATERIAL WAS REMOVED USING BIOPSY FORCEPS THROUGH A SHEATH. THE DAMAGE TO THE GRAFT WALL WAS CONSIDERED TO BE OCCURRED BY CONCENTRATION OF PUNCTURE SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2536912 GORE® ACUSEAL VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O