BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX® STRETCH VASCULAR GRAFT

    MDR report key: 15231389 · Received August 16, 2022

    Report

    Report Number
    2017233-2022-03215
    Event Type
    Injury
    Date Received
    August 16, 2022
    Date of Event
    January 19, 2022
    Report Date
    December 23, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    UDI-DI
    00733132612581
    PMA / PMN Number
    K903931
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS-REPORT FROM THIRD PARTY WAS RECEIVED AND WILL BE FURTHER INVESTIGATED. FURTHER INFORMATION RELATED TO THE PROCEDURE, THE INCIDENT AND THE PATIENT CONDITION WAS REQUESTED FROM THE HOSPITAL AND WERE CAPTURED IN THE ADVERSE EVENT DESCRIPTION. 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

    DURING INTERNAL SYSTEM UPGRADE, IMDRF CODES WERE INADVERTENTLY REMOVED FROM ORIGINAL MEDWATCH SUBMISSION.

    Additional Manufacturer Narrative · 0

    H6: CORRECT IMDRF CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT SURGICAL TREATMENT WITH A GORE-TEX® VASCULAR GRAFT. IT WAS RECORDED THAT THE VASCULAR GRAFT WAS IMPLANTED ON (B)(6) 2022, IN ORDER TO CREATE AN ACCESS FOR HEMODIALYSIS. REPORTEDLY, ON (B)(6) 2022, AFTER ABOUT 2 WEEKS, THE VASCULAR GRAFT WAS EXPLANTED DUE TO AN FISTULA STEAL SYNDROME. ACCORDING TO THE MOST RECENT INFORMATION, IT WAS REPORTED THAT ANOTHER DEVICE WAS IMPLANTED AND THAT THERE WAS NO ALLEGATION AGAINST THE GORE-TEX® VASCULAR GRAFT IN TERMS OF CONTRIBUTING TO THE FISTULA STEAL SYNDROME. REPORTEDLY, THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542975 GORE-TEX® STRETCH VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W. L. GORE & ASSOCIATES, INC. ST0507 00733132612581

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention