BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELSOFT PLUS

    MDR report key: 14630165 · Received June 8, 2022

    Report

    Report Number
    9612515-2022-00006
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    May 7, 2022
    Report Date
    July 21, 2022
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    UDI-DI
    05037881115566
    PMA / PMN Number
    K955230
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION FINDINGS: 3221 - NO FINDINGS ARE AVAILABLE - THE SITE PERFORMED CULTURE TESTING OF THE ALLEGED INFECTION MATERIAL FROM THE IMPLANT SITE. DESPITE MULTIPLE REQUESTS FOR THE FINDINGS OF THIS ANALYSIS, TEH RESULTS HAVE NOT BEEN COMMUNICATED TO VASCUTEK LTD.; THEREFORE IT IS IMPOSSIBLE TO DETERMINE A ROOT CAUSE. INVESTIGATION CONCLUSIONS: 4315 - CAUSE NOT ESTABLISHED - VASCUTEK LTD. PRODUCTS ARE STERILISED USING 100% ETHYLENE OXIDE WHICH IS A BACTERICIDAL CHEMICAL. THE STERILISATION PROCESS IS FULLY VALIDATED ENSURING A STERILITY ASSURANCE LEVEL (SAL) OF 10-6 USING BACILLUS ATROPHAEUS BIOLOGICAL INDICATORS. AS NO ISSUES WITH THE STERILE BARRIER PACKAGING WAS REPORTED TO US, THIS WOULD INDICATE THAT WHEN THE GRAFT WAS OPENED FROM ITS PROTECTIVE PACKAGING, IT WAS STERILE. UNFORTUNATELY AS THE RESULTS OF THE CULTURE TESTING PERFORMED BY THE SITE WAS NOT PROVIDED; IT HAS NOT BEEN POSSIBLE TO DETERMINE THE TYPE AND MODALITY OF THE REPORTED INFECTION; THEREFORE NO DETERMINATION OF ROOT CAUSE IS POSSIBLE.

    Description of Event or Problem · 0

    ON (B)(6) 2022 A PATIENT UNDERWENT SIGNIFICANT THORACO ABDOMINAL SURGERIES WHERE FOUR INDIVIDUAL GRAFTS WERE IMPLANTED (X1 GELWEAVE TRIFURCATE, X1 COSELLI, X1 GELWEAVE STRAIGHT AND X1 GELSOFT PLUS BIFURCATE). ON (B)(6) 2022 INFECTION WAS DETECTED AND IT WAS INDICATED THAT THE GELSOFT PLUS BIFURCATE GRAFT WHICH WAS IMPLANTED IS THE CAUSE AS THERE ARE NO SIGNS OF INFECTION WITH THE OTHER THREE GRAFTS IMPLANTED.

    Description of Event or Problem · 0

    EVENT INFORMATION UPDATED FROM THE INITIAL REPORT. ON (B)(6) 2022, A PATIENT HAD MULTIPLE GRAFTS (X4) MANUFACTURED BY VASCUTEK LTD. IMPLANTED (X3 GELWEAVE BRANDED DEVICES & X1 GELSOFT PLUS) IN AN EXTENSIVE THORACOABDOMINAL PROCEDURE. THE SITE STATED THAT ALL GRAFTS WERE PRE-SOAKED IN RIFAMPICIN PRIOR TO IMPLANT. ON 07 MAY 22 AN INCIDENTAL FINDING OF INFECTION WAS DETECTED DURING AN INTERVENTION PROCEDURE TO ARREST A BLEEDING ISSUE. DURING THE PROCEDURE ALL IMPLANTED GRAFTS APPEARED TO HAVE A YELLOW COLOURED SUBSTANCE WITH A SOFT CONSISTENCY ON AND AROUND THE GRAFTS. THIS MATERIAL WAS WASHED OFF THE GRAFTS, BUT THE GELSOFT BIFURCATE DID NOT APPEAR AS CLEAN AS THE OTHERS. THE SITE INDICATED THAT IT WAS BELIEVED THAT THE GELSOFT DEVICE MAY BE THE SOURCE.; THOUGH ALSO INDICATED THAT THE PROCEDURE ITSELF MAY HAVE BEEN A FACTOR. A SAMPLE OF THE YELLOW COLOURED SUBSTANCE WAS EXTRACTED AND ISSUED TO THE FACILITY'S LABORATORIES FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160762 GELSOFT PLUS GELSOFT PLUS BIFURCATE DSY VASCUTEK LTD GELSOFT PLUS BIFURCATE 22233666 05037881115566

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other