BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGISRX ANTIBACTERIAL ENVELOPE

    MDR report key: 2872121 · Received December 6, 2012

    Report

    Report Number
    3005619263-2012-00001
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    September 7, 2011
    Report Date
    October 22, 2012
    Manufacturer
    TYRX INC.
    Product Code
    FTL
    PMA / PMN Number
    K063091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS SUBMITTED AS NO CLEAR ROOT CAUSE COULD BE DETERMINED AND THE ROLE OF AIGIS CANNOT BE RULED OUT. THE EVENT WAS REPORTED TO THE COMPANY BY A COMPANY CLINICAL MONITOR AS PART OF A ROUTINE F/U FOR A POST-MARKETING STUDY. IT IS BELIEVED THAT NO PRODUCT COMPLAINT WAS FILED BY THE CLINICAL SITE. THE CLINICIAN WAS UNAVAILABLE FOR DIRECT INTERVIEW. THE SUPPORT STAFF WAS NOT PRESENT AT THE TIME OF THE IMPLANT OR EXPLANT, SO COULD PROVIDE NO FURTHER DETAILS. IN THE COMPANY¿S OPINION, THE ROLE OF THE AIGIS DEVICE IN THIS EVENT CANNOT BE RULED OUT. EROSION WAS REPORTED NEAR THE SURGICAL SITE FOR THE COMBINED IMPLANTATION OF THE AIGISRX ANTIBACTERIAL ENVELOPE AND CIED. NO INFECTION WAS REPORTED UNTIL AFTER DEHISCENCE AND EXPOSURE OF THE METAL CAN OCCURRED. REMOVAL OF BOTH THE AIGISRX ANTIBACTERIAL ENVELOPE AND CIED FOLLOWED BY INTRAVENOUS VANCOMYCIN ALLOWED THE PT TO SUBSEQUENTLY RECOVER. NO ENDOCARDITIS WAS OBSERVED. THE COMPANY WILL CONTINUE TO MONITOR ANY REPORTS OF PRODUCT SAFETY AND PERFORMANCE.

    Description of Event or Problem · 1

    PT RECEIVED AIGIS ICD ON (B)(6) 2011 AND WAS EXPLANTED ON (B)(6) 2011. IT WAS REPORTED THE PT DEVELOPED EROSION AT THE SURGICAL SITE WITH DEHISCENCE AND EXPOSURE OF THE CIED. SUBSEQUENTLY, AN INFECTION DEVELOPED. THE CIED AND AIGIS DEVICE WERE EXPLANTED. THE LEADS APPEAR TO HAVE BEEN LEFT IN PLACE. PT RECEIVED IV VANCOMYCIN FOR 12 DAYS. ENDOCARDITIS WAS NOT OBSERVED. PT SUBSEQUENTLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIGISRX ANTIBACTERIAL ENVELOPE AIGIS FTL TYRX INC. ICD 11C08214

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R CIED DEVICE - MFR AND MODEL UNK