BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE ACUSEAL VASCULAR GRAFT

    MDR report key: 8740424 · Received June 27, 2019

    Report

    Report Number
    2017233-2019-00471
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    June 7, 2019
    Report Date
    February 5, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K130215
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA:B5. DESCRIBE EVENT OR PROBLEM (SPELLING CORRECTION - RELINED).

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H6. DEVICE CODE 1. H6. CONCLUSIONS CODE 1. ADDITIONAL MANUFACTURER NARRATIVE: THERE ARE 2 FINDINGS FROM THE MANUFACTURER'S ANALYSIS THAT MAY BE CONSISTENT WITH THE SUSPECTED DELAMINATION. THE FIRST FINDING WAS A MINIMAL SEPARATION LIKELY DUE TO A SHALLOW ANGLE OF CANNULATION. THE SECOND FINDING OF SEPARATION IN THE 3RD SEGMENT IS LIKELY DUE TO CUTTING OF THE GRAFT POST EXPLANT. THERE WERE NO FINDINGS OF ANY MANUFACTURING ISSUES.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H6. RESULTS CODE 2. H6. CONCLUSIONS CODE 1. ADDITIONAL MANUFACTURER NARRATIVE: G5. PRE-1938. G5. OTC PRODUCT. EXAMINATION OF THE RETURNED DEVICE REVEALED THE FOLLOWING: THREE GORE® ACUSEAL VASCULAR GRAFT FRAGMENTS WERE RETURNED. THE FRAGMENTS HAD BEEN TRANSECTED PRIOR TO ARRIVAL AT W. L. GORE AND ASSOCIATES, INC.; MULTIPLE TRANSMURAL GRAFT PERFORATIONS WERE NOTED; CHARACTERISTICS OF THE PERFORATIONS WERE CONSISTENT WITH CANNULATION OF AN ARTERIOVENOUS ACCESS GRAFT; THE PERFORATION IN ONE SEGMENT ALIGNED WITH AN OBLIQUE TRANSMURAL PERFORATION IN THE OPPOSING WALL HISTOPATHOLOGICAL EXAMINATION OF THE TISSUE COULD NOT BE PERFORMED DUE TO THE LACK OF PROPER FIXATION PRIOR TO ARRIVAL AT W. L. GORE & ASSOCIATES, INC. FOLLOWING DIGESTION ALL DEVICES WERE EXAMINED FOR MATERIAL DISRUPTIONS WITH THE AID OF A STEREOMICROSCOPE. DISRUPTIONS IDENTIFIED WERE NOT ASSOCIATED WITH HANDLING OR MANUFACTURING PROCESS AT W.L. GORE AND ASSOCIATES, INC. THE DISRUPTIONS WERE CONSISTENT WITH MANUAL MANIPULATION VIA CANNULATION AND SURGICAL INSTRUMENTATION (E.G., SCALPEL, SCISSORS, AND SUTURE) WHICH WAS LIKELY USED DURING DIALYSIS AND/OR SURGICAL PROCEDURES.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE FROM THE DOCTOR: THERE WAS A SMALL INFECTION AT THE INCISION SITE, SO WHILE CLEANING THE SITE, THE DOCTOR REMOVED SEVERAL SMALL PIECES OF THE GORE® ACUSEAL® VASCULAR GRAFT AND RELINED WITH A GORE® VIABAHN® ENDOPROSTHESIS. THE REMAINDER OF THE GORE® ACUSEAL® VASCULAR GRAFT REMAINS IN PLACE AND IS FUNCTIONING AS INTENDED.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED AS NO LOT NUMBER INFORMATION WAS PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT MET RELEASE REQUIREMENTS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO GORE BY THE HOSPITAL: THE GORE® ACUSEAL® VASCULAR GRAFT HAD BEEN IMPLANTED IN THE PATIENT. ACCORDING TO THE DOCTOR, THE ITEM DELAMINATED AND WAS REMOVED FROM THE PATIENT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO GORE FROM THE DOCTOR: THERE WAS A SMALL INFECTION AT THE INCISION SITE, SO WHILE CLEANING THE SITE, THE DOCTOR REMOVED SEVERAL SMALL PIECES OF THE GORE® ACUSEAL® VASCULAR GRAFT AND REALIGNED WITH A GORE® VIABAHN® ENDOPROSTHESIS. THE REMAINDER OF THE GORE® ACUSEAL® VASCULAR GRAFT REMAINS IN PLACE AND IS FUNCTIONING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535240 GORE ACUSEAL VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES ECH470045A 6162378PP018

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention