BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIGIS

    MDR report key: 5244121 · Received November 23, 2015

    Report

    Report Number
    2182208-2015-03870
    Event Type
    Death
    Date Received
    November 23, 2015
    Date of Event
    October 1, 2015
    Report Date
    November 2, 2015
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    510(K)
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE DATE OF DEATH IS PURELY AN ESTIMATE, AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS (B)(6). WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: EFFICACY OF A BIO-ABSORBABLE ANTIBACTERIAL ENVELOPE TO PREVENT CARDIAC IMPLANTABLE ELECTRONIC DEVICE INFECTIONS IN HIGH-RISK SUBJECTS. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY,. 2015;26(10):1111-1116. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING ANTI-BACTERIAL ENVELOPES." OF NOTE, THESE ENVELOPES. RE USED TO PLACE THE CARDIAC IMPLANTABLE ELECTRONIC DEVICE (CIED) INTO TO HELP PREVENT INFECTION. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS THAT THERE WERE PATIENT DEATHS AND POCKET AND SYSTEMIC INFECTIONS NOTED. THERE WERE NO DEVICE ALLEGATIONS NOTED; AND MANY CIED SYSTEMS WERE EXPLANTED. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. THE CAUSE OF DEATH AND DEVICE RELATEDNESS HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THROUGH FOLLOW UP WITH THE COMPANY REPRESENTATIVE AND THE AUTHOR WHO INDICATED THAT THERE WERE NO PRODUCT ALLEGATIONS AGAINST THE "ENVELOPES" AND THEY WERE NOT THE CAUSE OF THE DEATH; THE DEATHS WERE RELATED TO THE CIED INFECTION. NO ADDITIONAL INFORMATION WAS AVAILABLE REGARDING THE CIEDS.

    Description of Event or Problem · 1

    ADDITIONAL CLARIFICATION WAS NEEDED; THE PATIENT DEATHS REFERENCED IN THE ARTICLE WERE IN THE "CONTROL ARM" OF THE STUDY; AND THESE PATIENTS DID NOT RECEIVE THE "ENVELOPE." NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773136 AIGIS MESH, SURGICAL, POLYMERIC FTL TYRX, INC. TYRX-AE

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Death| H| R