BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMAGARD KNITTED AXILLO

    MDR report key: 15249595 · Received August 18, 2022

    Report

    Report Number
    1640201-2022-00025
    Event Type
    Injury
    Date Received
    August 18, 2022
    Date of Event
    July 22, 2022
    Report Date
    October 24, 2022
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    DSY
    UDI-DI
    00384401015109
    PMA / PMN Number
    K964625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: BLOCK D9, H6 CODE (10) IS REPLACED BY CODE (4115). (4115) IT WAS INITIALLY INDICATED THAT THE DEVICE WAS AVAILABLE TO BE RETURNED. HOWEVER, THE INFORMATION WAS RECEIVED THAT THE PRODUCT WAS DISCARDED BY ACCIDENT BY THE HOSPITAL AND THUS IRRETRIEVABLY LOST FOR TESTING. (11/213) A VISUAL INSPECTION HAS BEEN PERFORMED BY THE QA SUPERVISOR ON THE RETENTION SAMPLE. HIS OBSERVATIONS ARE AS FOLLOWS: "THE GRAFT SHOWS NO ABNORMALITIES, THE EMBOSSING IS REGULAR. IT REACTS CORRECTLY WHEN HANDLED. NO NON-CONFORMITY RELATED TO THE EVENT DESCRIBED IN COMPLAINT (B)(4) WAS OBSERVED ON THIS PRODUCT. IT COMPLIES WITH THE SPECIFICATIONS." (4118/3233) MORE INFORMATION IS BEING SOUGHT REGARDING THE EVENT. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (4119/213) MORE DETAILS ABOUT THE EVENT DESCRIPTION WAS REQUESTED TO THE SURGEON, UNFORTUNATELY NO RELEVANT INFORMATION WAS RECEIVED. IT SHOULD BE NOTED THAT THE PRODUCT REFERENCE AFFECTED WAS ALREADY ORDERED BY THE HOSPITAL. (4112/213) THE CASE AND ITS INVESTIGATION HAVE BEEN REVIEWED BY THE MEDICAL AFFAIRS MANAGER WHO CONCLUDED THAT BASED ON THE LIMITED INFORMATION PROVIDED IN THIS COMPLAINT RECORD AND WITHOUT KNOWING THE SURGICAL DETAILS REGARDING THE IMPLANTATION OF THE INTERGARD (HEMAGARD) VASCULAR GRAFT, IT IS DIFFICULT TO ASCERTAIN THE EXACT CAUSE OF THE MISSHAPING OF GRAFT OR THE CAUSE OF THE RESISTANCE DURING FLUSHING OF THE GRAFT. (4315) THE INVESTIGATION CONCLUDED THAT NO CONCLUSION CAN BE DRAWN SINCE THE PRODUCT WAS DISCARDED AND THE LIMITED INFORMATION PROVIDED. HOWEVER, THE CONDUCTED INVESTIGATION AND TESTING PERFORMED SUGGEST THAT THE PRODUCT WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED TO INTERVASCULAR THAT A HEMAGARD KNITTED GRAFT APPEARED TO BE MISSHAPED. ILL FITTED. IT WAS EXPLANTED AN ANOTHER GRAFT HAD TO BE USED. THE DEVICE NOT USED. THE HEMAGARD GRAFT WAS BEVELED, AND ANASTOMOSED TO THE COMMON FEMORAL AND ONTO THE SFA WITH A RUNNING 5-0 PROLENE SUTURE. AT WHICH TIME THEY ATTEMPTED TO FLUSH THE GRAFT AND KEPT GETTING RESISTANCE. MULTIPLE ATTEMPTS MADE TO STRAIGHTEN IT OUT BUT WAS DEEMED INADEQUATE AND WOULD NOT HOLD ITS SHAPE. THE SURGERY WAS NOT DELAYED BECAUSE OF THE EVENT SINCE THEY HAD A SECOND ONE ON THE SHELF READY FOR USE.

    Description of Event or Problem · 0

    SEE MFG INITIAL REPORT . COMPLAINT (B)(4).

    Description of Event or Problem · 0

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2089846 HEMAGARD KNITTED AXILLO PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY INTERVASCULAR SAS HGKAX0808 21K14 00384401015109

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention