BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIGIS

    MDR report key: 5650632 · Received May 12, 2016

    Report

    Report Number
    3005619263-2016-00018
    Event Type
    Death
    Date Received
    May 12, 2016
    Date of Event
    July 1, 2015
    Report Date
    June 10, 2016
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE BASELINE GENDER/AGE OF THE PATIENTS REPRESENTED IN THE ARTICLE IS MALE/(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: ¿HEALTH AND ECONOMIC OUTCOMES ASSOCIATED WITH USE OF AN ANTIMICROBIAL ENVELOPE AS A STANDARD OF CARE FOR CARDIAC IMPLANTABLE ELECTRONIC DEVICE IMPLANTATION.¿ JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY VOL. 26, NO. 7, JULY 2015. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE AND THE SUBSEQUENT FOLLOW UP INFORMATION OBTAINED FROM THE AUTHOR. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. REFERENCED ARTICLE: ¿HEALTH AND ECONOMIC OUTCOMES ASSOCIATED WITH USE OF AN ANTIMICROBIAL ENVELOPE AS A STANDARD OF CARE FOR CARDIAC IMPLANTABLE ELECTRONIC DEVICE IMPLANTATION.¿ JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY VOL. 26, NO. 7, JULY 2015.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING USING AN ANTIBACTERIAL ENVELOPE WITH DEVICE IMPLANTATION. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE INDICATED THAT THERE WERE PATIENT DEATHS WHILE USING THE ENVELOPE. OF NOTE, THE INFORMATION RECEIVED DOES NOT SUGGEST THAT THE DEATHS WERE RELATED TO THE ENVELOPE. THERE WAS ALSO ONE PATIENT WHO HAD AN ALLERGIC REACTION, WHICH THE AUTHOR FELT WAS DUE TO "SOME ELEMENT" OF THE ENVELOPE. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION AND ANY ADDITIONAL INFORMATION PERTAINING TO THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT YET RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW UP WITH THE CO-AUTHOR/PHYSICIAN WHO INDICATED THAT THERE WERE NO ALLEGATIONS THAT THE WAS ANY RELATIONSHIP WITH THE PATIENT DEATHS AND THE USE OF THE PRODUCT NOR WERE THERE ANY ALLEGATIONS OF A PERFORMANCE ISSUE WITH THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305535 AIGIS MESH, SURGICAL, POLYMERIC FTL TYRX, INC. TYRX-AAE

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| R