BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELSOFT PLUS

    MDR report key: 15223752 · Received August 15, 2022

    Report

    Report Number
    9612515-2022-00012
    Event Type
    Injury
    Date Received
    August 15, 2022
    Date of Event
    June 26, 2022
    Report Date
    August 26, 2022
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    UDI-DI
    05037881115177
    PMA / PMN Number
    K955230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    SECTION B5 EVENT DESCRIPTION HAS BEEN ADJUSTED TO INCLUDE THE DATE THAT THIS EVENT NOTIFICATION WAS RECEIVED BY VASCUTEK LTD. SECTION D6 (A) HAD AN INCORRECT DATE DISPLAYED AS (B)(6) 2022. THE CORRECT DATE IS (B)(6) 2022.

    Additional Manufacturer Narrative · 0

    TYPE OF INVESTIGATION: 4112 - ANALYSIS OF DATA PROVIDED BY USER/THIRD PARTY - FURTHER INFORMATION / BIOPSY RESULTS WAS PROVIDED BY THE SITE - THE AFFECTED GRAFT WAS EXPLANTED ON (B)(6) 2022 AND IS UNAVAILABLE FOR RETURN TO VASCUTEK LTD. FOR ANALYSIS. THE SITE TESTED THE WOUND ON MULTIPLE OCCASIONS DURING THE TREATMENT PROCESS (B)(6) 2022, TO IDENTIFY THE CAUSE OF THE REPORTED INFECTION. NO INDICATION OF INFECTION OR INCIPIENT SEPSIS WAS FOUND. IT WAS INDICATED THAT THE GRAFT WAS REJECTED BY THE PATIENT'S BODY (CLINICAL OPINION OF THE SITE). HOWEVER IT WAS NOT INDICATED/CONFIRMED IF THE PATIENT WAS ALLERGIC TOO OR EXHIBITED SENSITIVITY TO POLYESTER OR MATERIALS OF BOVINE ORIGIN (THE GRAFTS CONSTRUCTED MATERIALS). SWAB TESTING OF THE WOUND SITE DID IDENTIFY THE BACTERIA KLEBSIELLA OXYTOCA. VASCUTEK LTD.'S ENVIRONMENTAL MONITORING AND BIOBURDEN TESTING HAS NEVER DETECTED KLEBSIELLA OXYTOCA WITHIN ITS MANUFACTURING PROCESSES. A REVIEW OF THIS TYPE OF BACTERIA INDICATES THAT IT IS COMMON TO WOUND SITE INFECTIONS. 4114 - DEVICE NOT ACCESSIBLE FOR TESTING - THE GRAFT WAS EXPLANTED AND IS NOT AVAILABLE. INVESTIGATION FINDINGS: 213 - NO DEVICE PROBLEM FOUND - NO ISSUE HAS BEEN FOUND UPON REVIEW OF THE RETAINED DEVICE / STERILISATION HISTORY RECORDS AND AVAILABLE INFORMATION PROVIDED BY THE SITE. INVESTIGATION CONCLUSIONS: 67 - NO PROBLEM DETECTED - THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. VASCUTEK LTD. PRODUCTS ARE STERILISED USING 100% ETHYLENE OXIDE WHICH IS A BACTERICIDAL CHEMICAL. THE STERILIZATION 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. SITE ALSO CONFIRMED THAT THE DEVICE WAS REJECTED BY THE PATIENTS BODY AND THEREFORE THIS EVENT IS NOT DEVICE RELATED. 22 - KNOWN INHERENT RISK OF DEVICE - POST OPERATIVE INFECTIONS ARE A KNOWN AND EXPECTED COMPLICATION FOLLOWING ANY INVASIVE PROCEDURE. INFECTION IS ALSO DOCUMENTED WITHIN THE DEVICE IFU AS A POTENTIAL ADVERSE EVENT.

    Description of Event or Problem · 0

    THIS EVENT WAS REPORTED VIA VASCUTEK LTD'S PANTHER STUDY PROGRAMME AS FOLLOWS: WOUND INFECTION WAS DETECTED AT THE GROIN AREA - BYPASS TUNNEL INFECTION AND THIGH INFECTION (DISTALLY). THE GELSOFT PLUS STRAIGHT VASCULAR PROSTHESIS WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2022 A WOUND INFECTION OF THE GROIN WAS DETECTED - BYPASS TUNNEL AND THIGH (DISTALLY) WAS DETECTED. THIS EVENT WAS REPORTED AS RELATED TO THE PROCEDURE AND DEVICE AND POSSIBLY RELATED TO A PATIENT PRE-EXISTING CONDITION. FOUR WOUND REVISION/IRRIGATION PROCEDURES WAS PERFORMED. THE WOUND WAS TREATED WITH NEGATIVE WOUND THERAPY (OVER 14 DAYS).

    Description of Event or Problem · 0

    THIS EVENT WAS REPORTED VIA VASCUTEK LTD'S PANTHER STUDY PROGRAMME ON 22 JUL 22 AS FOLLOWS: WOUND INFECTION WAS DETECTED AT THE GROIN AREA - BYPASS TUNNEL INFECTION AND THIGH INFECTION (DISTALLY). THE GELSOFT PLUS STRAIGHT VASCULAR PROSTHESIS WAS IMPLANTED ON (B)(6) 2022. ON 26 JUN 22 A WOUND INFECTION OF THE GROIN WAS DETECTED - BYPASS TUNNEL AND THIGH (DISTALLY). THIS EVENT WAS REPORTED TO VASCUTEK AS RELATED TO THE PROCEDURE AND DEVICE AND POSSIBLY RELATED TO A PATIENT PRE-EXISTING CONDITION. FOUR WOUND REVISION/IRRIGATION PROCEDURES WAS PERFORMED. THE WOUND WAS TREATED WITH NEGATIVE WOUND THERAPY (OVER 14 DAYS).

    Description of Event or Problem · 0

    THIS EVENT WAS REPORTED VIA VASCUTEK LTD'S PANTHER STUDY PROGRAMME ON 22 JUL 22 AS FOLLOWS: WOUND INFECTION WAS DETECTED AT THE GROIN GROIN AREA - BYPASS TUNNEL INFECTION AND THIGH INFECTION (DISTALLY). THE GELSOFT PLUS STRAIGHT VASCULAR PROSTHESIS WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2022 A WOUND INFECTION OF THE GROIN WAS DETECTED - BYPASS TUNNEL AND THIGH (DISTALLY). THIS EVENT WAS REPORTED TO VASCUTEK AS RELATED TO THE PROCEDURE AND DEVICE AND POSSIBLY RELATED TO A PATIENT PRE-EXISTING CONDITION. FOUR WOUND REVISION/IRRIGATION PROCEDURES WERE PERFORMED. THE WOUND WAS TREATED WITH NEGATIVE WOUND THERAPY (OVER 14 DAYS). GRAFT WAS EXPLANTED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988603 GELSOFT PLUS GESLOFT PLUS STRAIGHT DSY VASCUTEK LTD GELSOFT PLUS STRAIGHT 21945820 05037881115177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention