BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR

    MDR report key: 7925828 · Received October 2, 2018

    Report

    Report Number
    1640201-2018-00020
    Event Type
    Injury
    Date Received
    October 2, 2018
    Date of Event
    July 24, 2018
    Report Date
    March 24, 2020
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    MAL
    UDI-DI
    00384401018643
    PMA / PMN Number
    K021213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THE VIDEO OF THE SURGERY PROVIDED BY THE USER WAS ALSO CAREFULLY OBSERVED BY OUR CORPORATE MEDICAL OFFICER. HIS COMMENTS ARE AS FOLLOWS: "THE BLEEDING WAS MINIMAL BUT IT REQUIRED INTERVENTION (GLUE) TO STOP. SO IT WASN'T SELF-LIMITING AS OTHERS THAT STOPPED AFTER ADMINISTRATION OF PROTAMINE. I ASSUME PROTAMINE WAS ADMINISTERED AS THERE ARE NO EXTRACORPOREAL CANNULAS IN THE SURGICAL FIELD AND BECAUSE PROTAMINE IS GIVEN FIRST BEFORE ATTEMPTING OTHER METHODS AS BIOGLUE AS IN THIS PARTICULAR CASE." THE OUTCOME OF THE INVESTIGATION WOULD TEND TO INDICATE THAT THE ISSUE WAS RELATED TO STRETCHING OF THE WOVEN FABRIC DURING THE SEWING STEP. THE OBSERVED PHENOMENON OF MINIMAL CLINICAL SIGNIFICANCE, CONSTITUTES AN UNDETECTABLE BUT ACCEPTABLE DEFECT, ACCORDING TO OUR QUALITY CONTROL INSTRUCTIONS AND CURRENT PRODUCT SPECIFICATIONS. NEVERTHLESS, AS A PREVENTIVE MEASURE, AWARENESS OF ALL SEWING OPERATORS CONCERNING THE POTENTIAL RISK OF GREIGE STRETCHING DURING SEWING WAS RAISED AND QUALITY CONTROL INSTRUCTIONS WERE REINFORCED.

    Additional Manufacturer Narrative · 0

    DUE TO SIMILARITIES OF THE EVENTS DESCRIBED IN THE MFR REPORTS #1640201- 2018-00019, #1640201- 2018-00020, #1640201-2019-00021 #1640201-2019-00022,AND #1640201-2019-00077 , A HEALTH HAZARD EVALUATION HAS BEEN INITIATED IN RELATION WITH THESE FIVE CASES AND ASSESSED BY OUR CORPORATE MEDICAL OFFICER. PROBABILITY AND HEALTH RISK ARE DESCRIBED AS FOLLOWS: "THE MOST LIKELY OCCURRENCE AS A CONSEQUENCE OF THIS HOLE BLEEDING IS A PROCEDURAL DELAY DUE TO THE NECESSITY TO PERFORM AN ADDITIONAL HEMOSTASIS MEASURE. THE DELAY IS EXPECTED TO BE LIMITED AND NOT IMPACTING THE FLOW OF THE OPERATION AND ITS OUTCOME. IN THE EVENT OF INTRAOPERATIVE BLEEDING, IT WOULD, IN MOST CASES, BE CONTROLLED BY COMPRESSION, CLOTTING AGENT APPLICATION OR A SIMPLE SUTURE. THIS HOWEVER, CAN OCCASIONALLY RESULT IN A SERIOUS OR EVEN CRITICAL SITUATIONS FOR EITHER GENERAL OR AT GREATEST RISK POPULATIONS RESPECTIVELY. REOPERATION TO CONTROL POSTOPERATIVE BLEEDING IS A REMOTE POSSIBILITY THAT CAN BE CRITICAL ESPECIALLY FOR THE POPULATION AT GREATEST RISK. HOWEVER THE PRESENCE OF MEDIASTINAL DRAINAGE WILL MITIGATE THE POTENTIAL INCIDENCE OF TAMPONADE AND HELP IN PROMPTLY DETECT AN UNUSUAL BLEEDING. THE CRITICALITY OF THIS EVENT FOR THE HIGH-RISK POPULATION DERIVES FROM THE RE-OPERATION AND THE POTENTIAL IMPACT ON THE ALREADY DELICATE OVERALL CONDITION". FOLLOWING THIS EVALUATION, INTERVASCULAR HAS DECIDED TO WITHDRAW FROM THE MARKET ALL PRODUCTS POTENTIALLY AFFECTED. 1710 DEVICES ARE INVOLVED (RECALL # RC034 INITIATED ON 23-MAR-2020) A CAPA (#281548) HAS BEEN INITIATED IN ORDER TO INVESTIGATE AND TAKE APPROPRIATE CORRECTIVE ACTIONS. THE MOST LIKELY ROOT CAUSE(S) MAY BE A COMBINATION OF CONDITIONS: - LINKED TO THE SLIGHT STRETCHING OF THE WOVEN FABRIC EXPECTED DURING THE SEWING OPERATION, AS EXPLAINED IN INITIAL MFR REPORT #1640201- 2018-00019, #1640201- 2018-00020 (COMPLAINT #(B)(4)). -LINKED TO THE SEWING OPERATOR BEING STRESSED AFTER HAVING BEEN INFORMED ABOUT THE FIRST 2 COMPLAINTS (FOR THE THREE ADDITIONAL SIMILAR EVENTS, SEE INITIAL MFR REPORT #1640201-2019-00021, #1640201-2019-00022 AND #1640201-2019-00077 ; COMPLAINT #(B)(4)).

    Description of Event or Problem · 1

    DURING SURGERY FOR ANEURYSMAL DISEASE, THE GRAFT HAD A SERIOUS HOLE BLEEDING PROBLEM. THERE WAS NO TRANSFUSION DURING THE SURGERY. SURGEON USED DRUGS AS BIOGLUE TO STOP BLEEDING. THE PATIENT REMAINED IMPLANTED AND STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769843 HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR VASCULAR POLYESTER GRAFT MAL INTERVASCULAR SAS M00202175926P0 18E23 00384401018643

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention