BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4962691 · Received August 3, 2015

    Report

    Report Number
    2017233-2015-00507
    Event Type
    Injury
    Date Received
    August 3, 2015
    Date of Event
    November 15, 2010
    Report Date
    December 8, 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

    TYPE OF REPORTABLE EVENT CORRECTED TO "SERIOUS INJURY". REPORTABILITY OF PATIENT'S DEATH THE PATIENT EXPIRED THREE DAYS POST INITIAL IMPLANT PROCEDURE. ADDITIONALLY, THE PHYSICIAN ATTRIBUTES THE PATIENT¿S DEATH TO DEBRANCHING PROCEDURE INCLUDING DEBRANCHING GRAFT OCCLUSION AND EXTENDED TIME OF INITIAL IMPLANT PROCEDURE. FOR THESE ASPECTS, THE PATIENT¿S DEATH IS NOT RELATED TO THE DEVICE AND IT IS NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACO-ABDOMINAL AORTIC ANEURYSM USING TWO GORE TAG THORACIC ENDOPROSTHESES (TGT2610/8222435 AND TGT2610/8296447) AND TWO NON-GORE DEVICES. PRIOR TO IMPLANTATION OF THE STENT GRAFTS, ABDOMINAL AORTA WAS REPLACED USING A SURGICAL GRAFT AND A DEBRANCHING PROCEDURE WAS PERFORMED FOR BRANCH VESSELS OF THE ABDOMINAL AORTA. TWO TGT2615 DEVICES AND NON-GORE DEVICES WERE THEN DEPLOYED, AND THE SUPERIOR MESENTERIC ARTERY WAS COIL-EMBOLIZED FOR THE PREVENTION OF TYPE II ENDOLEAK. THE PROCEDURE WAS CONCLUDED WITHOUT ENDOLEAKS PRESENT. ON THE SAME DAY, THE PATIENT DEVELOPED RENAL FAILURE, AND CONTINUOUS HEMODIAFILTRATION (CHDF) WAS PERFORMED TO TREAT THE RENAL FAILURE. LATER, THE PATIENT FURTHER DEVELOPED ACIDOSIS AND MYONEPHROPATHIC METABOLIC SYNDROME (MNMS). ON (B)(6), 2010, THE PATIENT EXPIRED DUE TO RESPIRATORY AND HEMODYNAMIC FAILURE. REPORTEDLY, DEBRANCHING PROCEDURE WAS PERFORMED AND IT TOOK LONG TIME TO COMPLETE THE INITIAL PROCEDURE, WHICH COULD MAKE THE PATIENT SUFFER FROM THE RESPIRATORY AND HEMODYNAMIC FAILURE. THE CAUSE OF THE RENAL FAILURE, ACIDOSIS AND MNMS WAS OCCLUSION OF THE DEBRANCHING GRAFT. HOWEVER, ANY INTERVENTION WAS NOT PERFORMED TO RESTORE BLOOD FLOW THROUGH THE DEBRANCHING GRAFT. IT WAS ALSO REPORTED THAT THE PHYSICIAN THOUGHT THAT RENAL FAILURE, ACIDOSIS AND MNMS WAS DUE TO OCCLUSION OF THE DEBRANCHING GRAFT. HE ALSO THOUGHT THAT THE PATIENT'S DEATH WAS DUE TO LONG TIME BEING TAKEN TO COMPLETE THE INITIAL PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACO-ABDOMINAL AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES ((B)(4) AND (B)(4)) AND TWO NON-GORE DEVICES. PRIOR TO IMPLANTATION OF THE STENT GRAFTS, ABDOMINAL AORTA WAS REPLACED USING A SURGICAL GRAFT AND A DEBRANCHING PROCEDURE WAS PERFORMED FOR BRANCH VESSELS OF THE ABDOMINAL AORTA. TWO TGT2615 DEVICES AND NON-GORE DEVICES WERE THEN DEPLOYED, AND THE SUPERIOR MESENTERIC ARTERY WAS COIL-EMBOLIZED FOR THE PREVENTION OF TYPE II ENDOLEAK. THE PROCEDURE WAS CONCLUDED WITHOUT ENDOLEAKS PRESENT. ON THE SAME DAY, THE PATIENT DEVELOPED RENAL FAILURE, AND HEMODIALYSIS WAS PERFORMED. LATER, THE PATIENT FURTHER DEVELOPED ACIDOSIS AND MYONEPHROPATHIC METABOLIC SYNDROME (MNMS). ON (B)(6) 2010, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503420 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8222435

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death| H| L| R