BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® ACUSEAL VASCULAR GRAFT

    MDR report key: 4243341 · Received November 11, 2014

    Report

    Report Number
    2017233-2014-00585
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 3, 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

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

    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 LEFT LOWER ARM ON THE ARTERIAL SIDE OF THE GORE® ACUSEAL VASCULAR GRAFT. THE GRAFT IS CURRENTLY OPEN AND ABLE TO BE DIALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726048 GORE® ACUSEAL VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 4440636PP009

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention