BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELSOFT PLUS

    MDR report key: 6168739 · Received December 13, 2016

    Report

    Report Number
    9612515-2016-00033
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    September 30, 2016
    Report Date
    January 13, 2017
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    UDI-DI
    05037881115047
    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

    (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

    (B)(4). RESULTS - NO FAILURE DETECTED - PHYSICAL EVALUATION, SCANNING ELECTRON MICROSCOPY. EVALUATION IDENTIFIED NO ISSUES, GRAFT STRUCTURE WAS IN A GOOD STATE OF CONDITION AND THE FIBRES WERE TIGHT AND UNIFORM. QC AND MANUFACTURING RECORD REVIEW IDENTIFIED NO ISSUES WITH BATCH MANUFACTURE, QC INSPECTION OR STERILISATION PROCESSES. PATHOLOGICAL TESTING WAS INCONCLUSIVE; HOWEVER INITIAL TESTING BY CLINICIAN CONFIRMED NO SIGN OF INFECTION OR EFFUSION CONCLUSION - UNABLE TO CONFIRM THE COMPLAINT; NO FAILURE WAS DETECTED. 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. FROM A REVIEW OF VASCUTEK'S CLINICAL EVALUATION REPORT FOR POLYESTER VASCULAR GRAFTS AND A REVIEW OF RELEVANT CLINICAL PAPERS, IT HAS BEEN 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, THE PATIENT RECEIVED X2 VASCUTEK LTD. MANUFACTURED GELSOFT PLUS STRAIGHT GRAFTS AS PART OF A VASCULAR SYSTEM REPAIR. POST IMPLANT (6.5 YEARS) LATER THE PATIENT HAD DEVELOPED A SEROMA. ON (B)(6) 2016 (X2) SECTIONS OF ONE OF THE IMPLANTED GRAFTS WERE EXPLANTED AND REPLACED. (THIS WAS RECORDED AS COMP 3175 - FDA REF 9612515-2016-00022). FOLLOWING THIS, ON THE (B)(6) 2016, A THIRD SECTION OF THE GRAFT(S) WAS EXPLANTED DUE TO A SEROMA FORMATION. NO EFFUSION OR INFECTION WAS IDENTIFIED UPON GRAFT EXTRACTION.

    Description of Event or Problem · 1

    THIS REPORT FOR MFR 9612515-2016-00033 IS TO PROVIDE AN UPDATE REGARDING THE PROGRESS OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823403 GELSOFT PLUS GELSOFT PLUS GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS, PRODUCT DSY VASCUTEK LTD GELSOFT PLUS STRAIGHT 102152 05037881115047

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention