BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELSOFT PLUS

    MDR report key: 13007988 · Received December 15, 2021

    Report

    Report Number
    9612515-2021-00030
    Event Type
    Injury
    Date Received
    December 15, 2021
    Date of Event
    October 9, 2021
    Report Date
    January 14, 2022
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    UDI-DI
    05037881115337
    PMA / PMN Number
    K955230
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6 MANUFACTURERS NARRATIVE. INVESTIGATION FINDINGS - 213 - NO DEVICE PROBLEM WAS FOUND. VASCUTEK LTD COMPLETED REVIEW OF THE ASSOCIATED MANUFACTURING AND STERILISATION RECORDS FOR THESE DEVICES; ALL RECORDS INDICATE THAT THEY WERE MANUFACTURED AND PROCESSED AS PER SPECIFICATIONS. INVESTIGATION CONCLUSION - 4315 - CAUSE NOT ESTABLISHED - FOR THE FOLLOWING REASONS 1. THE INVESTIGATION CONDUCTED BY VASCUTEK LTD. CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. 2. THE REPORTING SITE TESTED ALL THE ASSOCIATED PATIENTS FOR SIGNS OF INFECTION; HOWEVER NONE WERE FOUND. 3. THE SITE ADVISED THAT THEY COULD NOT CONFIRM IF THE ASSOCIATED PATIENTS WERE ALLERGIC TO ANY OF THE MATERIALS USED IN THE CONSTRUCTION OF THE GRAFTS (E.G. POLYESTER MATERIAL OR THE GELATIN COATING). 4. REVIEW OF THE SUPPLIED IFU BOOKLET WITH THIS DEVICE TYPE INDICATES THAT FEVER AND LOCALISED INFLAMMATION OF SURGICAL SITES ARE A KNOWN AND EXPECTED OUTCOME/ADVERSE EVENT ASSOCIATED WITH THE IMPLANTATION OF GELSOFT PLUS GRAFTS. VASCUTEK CONSIDERS THIS EVENT AS CLOSED AS NO FURTHER INVESTIGATION IS POSSIBLE. FURTHER ACTION IS NOT PLANNED, HOWEVER, THE ISSUE WILL BE TRACKED AND TRENDED AS PART OF THE ON-GOING COMPLAINTS TRENDING AND REPORTING PROCESS AND IF AN ADVERSE TREND DEVELOPS ACTION MAY BE TAKEN AT THAT TIME.

    Additional Manufacturer Narrative · 0

    DEVICE INFORMATION: 1. CAT 631508P - LOT 21710963 - (B)(4). 2. CAT 631508P - LOT 21738467 - (B)(4). 3. CAT 631508P - LOT 21658411 - (B)(4). 4. CAT 631508P - LOT 21627121 - (B)(4). 5. CAT 631508P - LOT 21697742 - (B)(4). 6. CAT 631508P - LOT 21718971 - (B)(4). (B)(4).

    Description of Event or Problem · 0

    SERIOUS ADVERSE EVENTS WERE REPORTED RELATED TO GELSOFT PLUS PROSTHESES. IN (B)(6) 2021, (B)(4) DIFFERENT PATIENTS WERE IMPLANTED WITH GLESOFT PLUS STRAIGHT PROSTHESES. ALL (B)(4) PATIENTS EXPERIENCED SYSTEMIC SEPTIC SYMPTOMS WITH FEVER, HIGH INFLAMMATORY LOCAL RESPONSE WITHIN THE FIRST 24 HOURS POSTOPERATIVELY. IN ALL (B)(4) CASES BACTERIA/INFECTION WAS NOT DETECTED IN WOUND SWABS NOR IN BLOOD CULTURES. IN ONE CASE, THE PROSTHESIS HAD TO BE EXPLANTED, LEADING TO LIFE-THREATENING COMPLICATIONS AND TO IRREVERSIBLE CONSEQUENTIAL DAMAGE WITH PRESUMABLY LIFELONG CARE.

    Description of Event or Problem · 0

    SERIOUS ADVERSE EVENTS WERE REPORTED RELATED TO GELSOFT PLUS PROSTHESES. IN (B)(6) AND (B)(6) 2021, 6 DIFFERENT PATIENTS WERE IMPLANTED WITH GLESOFT PLUS STRAIGHT PROSTHESES. ALL 6 PATIENTS EXPERIENCED SYSTEMIC SEPTIC SYMPTOMS WITH FEVER, HIGH INFLAMMATORY LOCAL RESPONSE WITHIN THE FIRST 24 HOURS POSTOPERATIVELY. IN ALL 6 CASES BACTERIA/INFECTION WAS NOT DETECTED IN WOUND SWABS NOR IN BLOOD CULTURES. IN ONE CASE, THE PROSTHESIS HAD TO BE EXPLANTED, LEADING TO LIFE-THREATENING COMPLICATIONS AND TO IRREVERSIBLE CONSEQUENTIAL DAMAGE WITH PRESUMABLY LIFELONG CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906045 GELSOFT PLUS GELSOFT PLUS STRAIGHT DSY VASCUTEK LTD GELSOFT PLUS STRAIGHT REFER TO SECTION H10 05037881115337

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| O| R