BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® ACUSEAL VASCULAR GRAFT

    MDR report key: 4243353 · Received November 11, 2014

    Report

    Report Number
    2017233-2014-00587
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 13, 2014
    Report Date
    December 2, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K130215
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: THE DEVICE REMAINED IMPLANTED; CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. WITHOUT ADDITIONAL INFORMATION IT IS IMPOSSIBLE TO FURTHER INVESTIGATE THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A PATIENT WAS IMPLANTED WITH A GORE® ACUSEAL VASCULAR GRAFT FOR ARTERIOVENOUS ACCESS. THE DIALYSIS CENTER REPORTED TO GORE THAT ON (B)(6) 2014, THE GRAFT CLOTTED WHEN CANNULATED WITH A 15G NEEDLE IN THE MEDIAL ASPECT OF THE RIGHT LOWER ARM ON THE VENOUS RETURN SIDE OF THE GORE® ACUSEAL VASCULAR GRAFT. ON (B)(6) 2014, THE GRAFT CLOTTED WHEN CANNULATED WITH A 15G NEEDLE IN THE LATERAL ASPECT OF THE RIGHT LOWER ARM ON THE ARTERIAL OUTFLOW SIDE OF THE GORE® ACUSEAL VASCULAR GRAFT. THE GRAFT IS CURRENTLY OPEN AND ABLE TO BE DIALIZED.

    Description of Event or Problem · 1

    THE GRAFT IS STILL IMPLANTED BUT THE CLOTS HAVE BEEN REMOVED AND IT IS DIFFICULT TO DIALYZE THE PATIENT THROUGH THE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726051 GORE® ACUSEAL VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 4492471PP009

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention