BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® ACUSEAL VASCULAR GRAFT

    MDR report key: 3854063 · Received June 6, 2014

    Report

    Report Number
    2017233-2014-00295
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    July 20, 2013
    Report Date
    June 30, 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: 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. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE WAS NOT RETURNED; CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. NO FURTHER INFORMATION IS AVAILABLE. WITHOUT ADDITIONAL INFORMATION IT IS IMPOSSIBLE TO FURTHER INVESTIGATE THIS EVENT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE STERILIZATION RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A PATIENT IN A STUDY WAS IMPLANTED WITH A GORE® ACUSEAL® VASCULAR GRAFT FROM THE LEFT SUPERFICIAL FEMORAL ARTERY TO THE FEMORAL VEIN. ON (B)(6) 2013, THE GRAFT WAS FIRST CANNULATED. ON (B)(6) 2013, THE PATIENT PRESENTED WITH THROMBOSIS AND STENOSIS AND A DECLOT PROCEDURE AND ANGIOPLASTY WAS PERFORMED. A HEMATOMA WAS OBSERVED FOLLOWING THE PROCEDURE. ON (B)(6) 2013 THE PATIENT PRESENTED WITH AN INFECTED HEMATOMA AND AN INFECTED AND CLOTTED GRAFT. HEMATOMA FROM LAST ANGIOPLASTY PUNCTURE SITE IS BELIEVED TO BE SOURCE OF INFECTION. AN INFECTED HEMATOMA IN A NON-FUNCTIONING GRAFT. ON (B)(6) 2013, THE GRAFT WAS EXPLANTED AFTER A PROLONGED COURSE OF ANTIBIOTICS. THE PATIENT IS RECEIVING DIALYSIS WITH A CONTRALATERAL THIGH GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330901 GORE® ACUSEAL VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 3641490PP013

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention