BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE ACUSEAL VASCULAR GRAFT

    MDR report key: 10084998 · Received May 25, 2020

    Report

    Report Number
    2017233-2020-00384
    Event Type
    Injury
    Date Received
    May 25, 2020
    Date of Event
    April 7, 2020
    Report Date
    April 29, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K130215
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT WAS DEFINED AS THE DATE WHEN THE ARTICLE WAS PUBLISHED. THE LITERATURE ARTICLE ¿DISSECTION OF A SHUNT PROSTHESIS: VISUAL DIAGNOSIS ON DUPLEX ULTRASOUND¿, PUBLISHED BY YOUSEFI O ET AL, WITHIN THE ¿GEFÄSSCHIRURGIE¿ JOURNAL WAS RECEIVED AND PROCESSED. PRODUCT SURVEILLANCE COORDINATOR REQUESTED ADDITIONAL INFORMATION FROM THE AUTHOR WHERE FEEDBACK WAS RECEIVED THAT NO FURTHER INFORMATION WILL BE SHARED.

    Description of Event or Problem · 1

    WITHIN THE ARTICLE ¿DISSECTION OF A SHUNT PROSTHESIS: VISUAL DIAGNOSIS ON DUPLEX ULTRASOUND¿, PUBLISHED BY YOUSEFI O ET AL, WITHIN THE ¿GEFÄSSCHIRURGIE¿ JOURNAL, THE ARTICLE INDICATES THE FOLLOWING: THE FOLLOWING CASE REPORT DESCRIBES THE DIAGNOSTIC PROCEDURE AND TREATMENT STRATEGY FOR AN ACUTE LOOP SHUNT CLOSURE IN THE PATIENT¿S THIGH, RESULTING FROM EARLY SHUNT PUNCTURING. DUE TO A LACK OF SUITABLE VEIN MATERIAL IN A (B)(6) DIALYSIS PATIENT, AN ARTERIOVENOUS PROSTHETIC LOOP SHUNT (GORE® ACUSEAL VASCULAR GRAFT, 6 MM) WAS IMPLANTED IN THE PATIENT¿S RIGHT THIGH. THE ARTICLE STATES THAT A DUPLEX SONOGRAPHY REVEALED A LONGITUDINAL DISSECTION OF ONE PORTION OF THE IMPLANTED PROSTHESIS (4 CM LONG) IN THE ARTERIAL PART SECTION. THE REMAINING PARTS OF THE PROSTHESIS WERE NORMAL AND INTACT. THE DISSECTION WAS CONFIRMED INTRAOPERATIVELY. IN ANOTHER PROCEDURE A NEW PROSTHESIS SEGMENT WAS IMPLANTED (BARD VENAFLO® LL VASCULAR GRAFT, STRAIGHT, 6 MM). THE POSTOPERATIVE COURSE WAS STRAIGHTFORWARD AND THE PATIENT WAS DISCHARGED ON TIME. DISSECTION OF AN EARLY-PUNCTURABLE SHUNT PROSTHESIS IS A RARE COMPLICATION. A SIMILAR PROBLEM HAS NOT BEEN PREVIOUSLY DESCRIBED IN THE LITERATURE. IN THE CASE OF SHUNT OCCLUSIONS OCCURRING IN AN EARLY-PUNCTURABLE THE PRESENCE OF A DISSECTION MUST BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548702 GORE ACUSEAL VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention