BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELSOFT PLUS

    MDR report key: 5808425 · Received July 20, 2016

    Report

    Report Number
    9612515-2016-00022
    Event Type
    Injury
    Date Received
    July 20, 2016
    Date of Event
    June 24, 2016
    Report Date
    January 13, 2017
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    PMA / PMN Number
    K955230
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS IN TRANSIT TO VASCUTEK FOR ANALYSIS. ONCE THE DEVICE ANALYSIS IS COMPLETE, THE CONCLUSION OF OUR INVESTIGATION WILL BE PROVIDED. (B)(4). ONCE THE EXPLANTED GRAFTS HAVE BEEN RETURNED AND ASSESSED, A FULL REPORT OF THE FINDINGS / CONCLUSIONS WILL BE PROVIDED. .

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ANALYSIS OF THE AFFECTED GRAFT WAS ORIGINALLY TO BE PERFORMED BY A THIRD PARTY COMPANY. HOWEVER, DUE TO EXPECTED DELAYS WITH THE TIMELY COMPLETION OF THE EVALUATION, THEIR EVALUATION OF THE SAMPLE WAS CANCELLED. VASCUTEK LTD. HAS PERFORMED THE ANALYSIS OF 1 / 2 SECTIONS). THE 2ND SECTION IS CURRENTLY AWAITING RETURN BACK TO VASCUTEK FOR ASSESMENT. ONCE RECEIVED AND THE ANALYSIS OF THE 2ND SECTION IS COMPLETE; THE FINDINGS WILL BE ADDED TO THE NEXT FOLLOW UP REPORT. PATHOLOGICAL TESTING HAS BEEN PERFORMED ON SECTION 2 BY ANOTHER TERUMO COMPANY ON VASCUTEK LTD'S BEHALF. ONCE THE FINDINGS HAVE BEEN COMMUNICATED, THIS DATA WILL BE ADDED TO THE NEXT AVAILABLE REPORT. (B)(4). (B)(4). A REVIEW OF THE OVERALL SEROMA RATES SHOWS NO ADVERSE TRENDS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THE REPORTED SEROMA FROM VASCUTEK'S INVESTIGATION OF THE RETURNED SECTION (ONE) OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    CONCLUSION NOT YET AVAILABLE - EVALUATION IN PROGRESS. VASCUTEK HAS RECEIVED THE ACTUAL DEVICE SAMPLE FOR EVALUATION; HOWEVER VASCUTEK IS RELAYING THE DEVICE TO A THIRD PARTY INVESTIGATION COMPANY IN (B)(4) TO PERFORM PATHOLOGICAL EXAMINATIONS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATHOLOGICAL TESTING HAS BEEN PERFORMED ON SECTION 2 OF THE GRAFT. VASCUTEK'S OCCURRENCE RATE FOR THIS TYPE OF EVENT (SEROMA) IN GELSOFT GRAFTS (INCLUSIVE OF ALL VARIANTS OF GELSOFT & GELSOFT PLUS VASCULAR GRAFTS) IS (B)(4) WHICH IS LOWER THAN RATES STATED IN THE CLINICAL PAPERS. A REVIEW OF THE OVERALL SEROMA RATES SHOWS NO ADVERSE TRENDS. A REVIEW OF VASCUTEK'S CLINICAL EVALUATION REPORT RELEVANT CLINICAL PAPERS FOR POLYESTER VASCULAR GRAFTS, IT WAS NOTED THAT SEROMA FORMATION IS A KNOWN AND EXPECTED COMPLICATION OF THIS TYPE OF PROCEDURE. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THE REPORTED SEROMA FROM VASCUTEK'S INVESTIGATION OF THE RETURNED DEVICE. NO FURTHER ACTIONS ARE REQUIRED HOWEVER, THE ISSUE WILL BE TRACKED AND TRENDED AS PART OF THE ROUTINE COMPLAINTS MONITORING AND REPORTING PROCESS. IF AN ADVERSE TREND DEVELOPS ACTION MAY BE TAKEN AT THAT TIME. VASCUTEK CONSIDERS THIS EVENT AS CLOSED.

    Description of Event or Problem · 1

    VASCUTEK LTD. WAS NOTIFIED OF AN EVENT THAT OCCURRED IN (B)(6); THE EVENT WAS DESCRIBED AS FOLLOWS: ON THE (B)(6) 2009 TWO VASCUTEK LTD. MANUFACTURED GELSOFT PLUS STRAIGHT GRAFTS WERE IMPLANTED AS PART OF A VASCULAR SYSTEM REPAIR. APPROXIMATELY 6.5 YEARS LATER THE PATIENT DEVELOPED A SEROMA. ON (B)(6) 2016, TWO VASCUTEK MANUFACTURED GELSOFT PLUS GRAFTS WERE EXPLANTED AND REPLACED WITH UNKNOWN DEVICES.

    Description of Event or Problem · 1

    THIS REPORT FOR MFR 9612515-2016-00022 IS TO PROVIDE AN UPDATE REGARDING THE PROGRESS OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THIS REPORT FOR MFR 9612515-2016-00022 IS TO PROVIDE AN UPDATE REGARDING THE PROGRESS OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462689 GELSOFT PLUS GELSOFT PLUS GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS, PRODUCT DSY VASCUTEK LTD GELSOFT PLUS STRAIGHT 102152

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention