BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® ACUSEAL VASCULAR GRAFT

    MDR report key: 3849673 · Received June 4, 2014

    Report

    Report Number
    2017233-2014-00290
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    November 5, 2012
    Report Date
    May 14, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K130215
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS FROM THE FOLLOWING LITERATURE ARTICLE: (SEE ATTACHMENT BELOW) AITKEN EL, JACKSON AJ, KINGSMORE DB. EARLY CANNULATION PROSTHETIC GRAFT (ACUSEAL¿) FOR ARTERIOVENOUS ACCESS: A USEFUL OPTION TO PROVIDE A PERSONAL VASCULAR ACCESS SOLUTION. JOURNAL OF VASCULAR ACCESS. IN PRESS. NO LOT NUMBER INFORMATION WAS SUPPLIED; THEREFORE, NO REVIEW OF THE MANUFACTURING PAPERWORK COULD BE PERFORMED. THE DEVICE REMAINED IMPLANTED; CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. NO FURTHER INFORMATION IS AVAILABLE. WITHOUT ADDITIONAL INFORMATION IT IS IMPOSSIBLE TO FURTHER INVESTIGATE THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A PATIENT IN A STUDY WAS IMPLANTED WITH A GORE® ACUSEAL® VASCULAR GRAFT FROM THE RIGHT SUPERFICIAL FEMORAL ARTERY TO THE FEMORAL VEIN. ON (B)(6) 2012, THE GRAFT WAS FIRST CANNULATED. ON (B)(6) 2012, THE PATIENT PRESENTED WITH THROMBOSIS AND VENOUS STENOSIS. AN UNSUCCESSFUL DECLOT PROCEDURE WAS PERFORMED. THE PATIENT RECEIVED A TRANSPLANTED KIDNEY WHICH FAILED. THE PATIENT IS NOW PERFORMING PERITONEAL DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326957 GORE® ACUSEAL VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention