BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® ACUSEAL VASCULAR GRAFT

    MDR report key: 21290874 · Received February 3, 2025

    Report

    Report Number
    2017233-2025-05785
    Event Type
    Injury
    Date Received
    February 3, 2025
    Date of Event
    October 19, 2024
    Report Date
    February 3, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    PMA / PMN Number
    K130215
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. 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® ACUSEAL VASCULAR GRAFT INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO: MECHANICAL DAMAGE OR TEARING OF THE SUTURE LINE, GRAFT, AND/OR HOST VESSEL, PARTIAL OR COMPLETE OCCLUSION DUE TO HEMODYNAMICALLY SIGNIFICANT STENOSIS OR THROMBOSIS. LITERATURE TITLE : A CASE OF VASCULAR GRAFT DISSECTION AS A SUSPECTED CAUSE OF SHUNT OCCLUSION ON ULTRASONOGRAPHY SOURCE : THE JOURNAL OF JAPANESE COLLEGE OF ANGIOLOGY (0387-1126)64, SUPPL.PAGE S207 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: TITLE: A CASE OF VASCULAR GRAFT DISSECTION AS A SUSPECTED CAUSE OF SHUNT OCCLUSION ON ULTRASONOGRAPHY. SOURCE: THE JOURNAL OF JAPANESE COLLEGE OF ANGIOLOGY (0387-1126)64, SUPPL. PAGE S207. <CASE 1> A 67-YEAR-OLD FEMALE HAVE BEEN ON DIALYSIS FOR 7 YEARS WITH A LOOP AVG (GORE® ACUSEAL VASCULAR GRAFT, 6MM) IN HER RIGHT FOREARM. SHE HAD UNDERGONE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) FOR REPEATED STENOSIS, AND THIS TIME SHE WAS TRANSFERRED TO OUR FACILITY AS SUSPECT OF THE SHUNT OCCLUSION DURING DIALYSIS. AT THE TIME OF ARRIVAL, ULTRASONOGRAPHY CONFIRMED THAT THE SHUNT WAS OCCLUDED WITH THROMBUS, AND THE POSTERIOR SURFACE OF THE VASCULAR GRAFT ON THE VENOUS SIDE WAS PARTIALLY DEFORMED AND STENOTIC. THE VASCULAR GRAFT DISSECTION WAS SUSPECTED. PERCUTANEOUS THROMBECTOMY AND PTA WERE PERFORMED, BUT THERE WAS NO SUFFICIENT IMPROVEMENT IN BLOOD FLOW AND RECANALIZATION WAS DIFFICULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2189532 GORE® ACUSEAL VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention