BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4907971 · Received July 12, 2015

    Report

    Report Number
    2017233-2015-00417
    Event Type
    Death
    Date Received
    July 12, 2015
    Date of Event
    June 29, 2010
    Report Date
    August 14, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT/SERIAL:(B)(4)

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    ADDED THE DETAIL INFORMATION ON PATIENT'S DEATH THAT WAS OBTAINED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING THREE GORE® TAG® THORACIC ENDOPROSTHESES (TGT3415/7791988, TGT3420/7858631 AND TGT3720/7674277). AN INTRA-PROCEDURE IMAGING REVEALED A TYPE III ENDOLEAK, BUT THE PROCEDURE WAS CONCLUDED WITH A WAIT-AND-WATCH APPROACH BEING TAKEN TO THE ENDOLEAK. ON (B)(6) 2010, A FOLLOW-UP REVEALED THAT THE TYPE III ENDOLEAK HAD PERSISTED. ANEURYSM DIAMETER WAS 72MM. ON (B)(6)2010, IN SIX-MONTH FOLLOW-UP STUDY, THE TYPE III ENDOLEAK HAD BEEN RESOLVED, BUT A DISTAL TYPE I ENDOLEAK WAS NEWLY PRESENT. ANEURYSM DIAMETER WAS 72MM. A WAIT-AND-WATCH APPROACH WAS TAKEN TO THE ENDOLEAK. ON (B)(6)2011, THE PATIENT SUFFERED FROM ANEURYSM RUPTURE. ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH A NON-GORE DEVICE TO TREAT THE ANEURYSM RUPTURE. ON (B)(6)2011, THE PATIENT EXPIRED DUE TO MULTIPLE ORGAN FAILURE. IT WAS REPORTED THAT AFTER THE REINTERVENTION WAS PERFORMED, ANEURYSM RUPTURE ITSELF WAS REPAIRED AND THE PATIENT WAS TRANSFERRED BACK TO AN INTENSIVE CARE UNIT. HOWEVER, THE PATIENT COULD NOT RECOVER FROM SHOCK DUE TO ANEURYSM RUPTURE, AND HIS HEALTH CONDITION HAD BEEN WORSENING AFTER THE REINTERVENTION. THE PATIENT THEN DEVELOPED MULTIPLE ORGAN FAILURE AND EXPIRED ON (B)(6) 2011. ADDITIONALLY, ANY RESUSCITATION WAS NOT PERFORMED FOR THE PATIENT WHEN HE DEVELOPED MULTIPLE ORGAN FAILURE. IT WAS ALSO REPORTED THAT AS THE ANEURYSM RUPTURE ITSELF WAS REPAIRED BY REINTERVENTION, MULTIPLE ORGAN FAILURE WAS NOT RELATED TO OUR DEVICES.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING THREE GORE® TAG® THORACIC ENDOPROSTHESES (TGT3415/7791988, TGT3420/7858631 AND TGT3720/7674277). AN INTRA-PROCEDURE IMAGING REVEALED A TYPE III ENDOLEAK, BUT THE PROCEDURE WAS CONCLUDED WITH A WAIT-AND-WATCH APPROACH BEING TAKEN TO THE ENDOLEAK. ON (B)(6) 2010, A FOLLOW-UP REVEALED THAT THE TYPE III ENDOLEAK HAD PERSISTED. ANEURYSM DIAMETER WAS 72MM. ON (B)(6) 2010, IN SIX-MONTH FOLLOW-UP STUDY, THE TYPE III ENDOLEAK HAD BEEN RESOLVED, BUT A DISTAL TYPE I ENDOLEAK WAS NEWLY PRESENT. ANEURYSM DIAMETER WAS 72MM. A WAIT-AND-WATCH APPROACH WAS TAKEN TO THE ENDOLEAK. ON (B)(6) 2011, THE PATIENT SUFFERED FROM ANEURYSM RUPTURE. ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH A NON-GORE DEVICE TO TREAT THE ANEURYSM RUPTURE. ON (B)(6) 2011, THE PATIENT EXPIRED DUE TO THE ANEURYSM RUPTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451642 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7791988

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death