BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® ACUSEAL VASCULAR GRAFT

    MDR report key: 16011097 · Received December 19, 2022

    Report

    Report Number
    2017233-2022-03587
    Event Type
    Injury
    Date Received
    December 19, 2022
    Date of Event
    September 1, 2022
    Report Date
    April 4, 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

    UPDATED B1. UPDATED TYPE OF REPORTABLE EVENT.

    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. 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

    PRODUCT EVALUATION: THE IDENTITIES OF THE DEVICES WERE NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE EXAMINED TO IDENTIFY ANY POTENTIAL ROOT CAUSES ATTRIBUTABLE TO THE MANUFACTURE OF THE DEVICES. THE CASE DESCRIPTION COULD NOT BE CONFIRMED, AS NO IDENTITIES OR IMAGES OF THE DEVICES WERE PROVIDED FOR EVALUATION. THE REPORTED FAILURE MODES REFLECT THE CASE DESCRIPTION BUT COULD NOT BE CONFIRMED. THE EVALUATION FOUND NO ANOMALIES ATTRIBUTABLE TO THE MANUFACTURE OF THE DEVICES.

    Additional Manufacturer Narrative · 0

    UPDATED H6 CLINICAL CODE, IMPACT CODE, AND INVESTIGATION CONCLUSION. ATTACHED ARTICLE.

    Description of Event or Problem · 0

    THE FOLLOWING LITERATURE WAS REVIEWED. ¿INVESTIGATION ON LONG-TERM RESULTS OF EARLY PUNCTURE TYPE HEPARIN COVALENT VASCULAR GRAFT (ACUSEAL)¿ MITSUHIRO SEKIJIMA, ET AL. KIDNEY AND DIALYSIS, 2022: 93(SEPARATE VOLUME ACCESS 2022) P.187-189. IT WAS REPORTED THAT 270 CASES, WHICH WERE IMPLANTED GORE® PROPATEN® VASCULAR GRAFT OR GORE® ACUSEAL VASCULAR GRAFT FROM JANUARY 2016 TO OCTOBER 218 AND EXPERIENCED OVER 3 YEARS FOLLOW-UP OBSERVATION, WERE INVESTIGATED. THERE WERE 119 CASES WHICH WERE IMPLANTED GORE® ACUSEAL VASCULAR GRAFT AND 151 CASES WHICH WERE IMPLANTED GORE® PROPATEN® VASCULAR GRAFT. REGARDING THE PATIENT BACKGROUND, THERE WAS NO SIGNIFICANT DIFFERENCE ABOUT AGE, GENDER, DIALYSIS TERM, PREVALENCE RATE OF DIABETES BETWEEN GORE® ACUSEAL VASCULAR GRAFT IMPLANTED CASES AND GORE® PROPATEN® VASCULAR GRAFT IMPLANTED CASES. THREE CASES IN GORE® ACUSEAL VASCULAR GRAFT IMPLANTED CASES EXPERIENCED A DELAMINATION. THE REPLACEMENT OF THE DELAMINATION SITE WAS PERFORMED TO TREAT IT. THE CAUSE OF THE DELAMINATION WAS CONSIDERED EXCESSIVE PUNCTURE AT SAME AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2748175 GORE® ACUSEAL VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other