BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERI-GUARD

    MDR report key: 137785 · Received December 6, 1997

    Report

    Report Number
    2183620-1997-00021
    Event Type
    Injury
    Date Received
    December 6, 1997
    Date of Event
    August 10, 1997
    Report Date
    December 5, 1997
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    MFX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON PROVIDED ADD'L INFO REGARDING THIS INCIDENT AS FOLLOWS: THE PT EXPERIENCED A 75% RESTENOSIS OF AN ICA 5 1/2 YRS POST-IMPLANT. THE SURGEON PERFORMED AN ENDOARTERIECTOMY AND REPLACED THE PERI-GUARD PATCH WITH A VASCU-GUARD PATCH, LOT # VGS-96L17-080 MFG BY BIO-VASCULAR, INC. THE SURGEON STATED THAT HE DOES NOT ATTRIBUTE THIS INCIDENT TO THE USE OF THE PERI-GUARD TISSUE PATCH. NO HARM CAME TO THE PT AND THE PT IS IN GOOD CONDITION WITH NO ADVERSE SYMPTOMS 4 MOS POST-EXPLANT. AN EVAL OF THE EXPLANT SPECIMEN WAS PERFORMED AT BIO-VASCULAR, INC. THE RESULTS OF THE ANALYSIS ARE AS FOLLOWS: THE HOST ARTERY WALL APPEARED TO HAVE FUSED WITH THE PATCH MATERIAL WITHOUT ANY LONG-STANDING INFLAMMATION AND THERE WAS NO INDICATION OF PATCH DEGENERATION FROM CROSS-SECTIONAL HISTOLOGIC VIEWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERI-GUARD Implant PERICARDIAL PATCH MFX BIO-VASCULAR, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR