BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5467175 · Received February 29, 2016

    Report

    Report Number
    2017233-2016-00180
    Event Type
    Death
    Date Received
    February 29, 2016
    Date of Event
    February 7, 2011
    Report Date
    March 4, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.(B)(4).

    Description of Event or Problem · 1

    RECEIVED ADDITIONAL INFORMATION/CLARIFICATION OF EVENT: THE FISTULA COMMUNICATED WITH THE SURGICAL GRAFT WHICH HAD REPLACED THE THORACIC AORTA. PART OF THE TAG DEVICES WERE WITHIN THE SURGICAL GRAFT WHICH COMMUNICATED THE FISTULA, BUT NOT DIRECTLY CONTACTED. CAUSE OF THE FISTULA WAS UNKNOWN. HOWEVER, AS THE PHYSICIAN CONSIDERED THE EVENT WAS RELATED TO THE REPLACEMENT SURGERY PRIOR TO THE TAG DEVICE IMPLANT, THE FISTULA WAS REPORTEDLY NOT RELATED TO THE TAG DEVICES OR THE PROCEDURE. IT WAS UNKNOWN IF THE TAG DEVICES WERE INFECTED. THE PATIENT'S CONDITION WAS NOT WELL ENOUGH TO ENDURE AN OPEN SURGERY TO REPAIR THE FISTULA, AFTER TWO THORACOTOMY, ONE LAPAROTOMY, AND STENT GRAFT IMPLANT AT THE THORACO-ABDOMINAL AORTA HAD BEEN PERFORMED. CAUSE OF THE DEATH WAS THE AORTOESOPHAGEAL FISTULA. NO AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, THIS PATIENT UNDERWENT REPLACEMENT SURGERY OF THE DISTAL AORTIC ARCH, DESCENDING AORTA, AND ABDOMINAL AORTA. ON (B)(6) 2011, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (PROXIMAL: TGT3415/8603172, DISTAL: TGT3410/7852624). THE PROXIMAL NECK OF THE DEVICES WERE PLACED WITHIN THE SURGICAL GRAFT IN THE AORTIC ARCH. IT WAS REPORTED THAT A NON-GORE FENESTRATED STENT GRAFT WAS SIMULTANEOUSLY IMPLANTED AT THORACOABDOMINAL AREA, AND THE BOTH RENAL ARTERIES WERE FENESTRATED WITH THE DEVICE. THE CELIAC AND SUPERIOR MESENTERIC ARTERIES WERE REPORTEDLY DEBRANCHED AS WELL. FINAL ANGIOGRAPHY SHOWED AN ENDOLEAK OF UNKNOWN TYPE RELATED TO THE THORACIC AORTIC ANEURYSM, AND THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2011, POST-OPERATIVE FOLLOW-UP IMAGING SHOWED RESOLUTION OF THE UNKNOWN ENDOLEAK WITH NO ADDITIONAL TREATMENT; HOWEVER IT ALSO REVEALED A TYPE II ENDOLEAK OF UNKNOWN ORIGIN. THE DIAMETER OF THE ANEURYSM WAS 52 MM. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. ON (B)(6) 2011, SIX MONTH FOLLOW-UP IMAGING SHOWED RESOLUTION OF THE TYPE II ENDOLEAK WITH NO ADDITIONAL TREATMENT. THE DIAMETER OF THE ANEURYSM WAS 52 MM. SUBSEQUENT FOLLOW-UP IMAGING SHOWED NO ISSUES WITH SHRINKAGE OF THE ANEURYSM TO 50 MM. ON (B)(6) 2015, THE PATIENT EXPIRED DUE TO AN AORTOESOPHAGEAL FISTULA. NO FURTHER INFORMATION REGARDING THE PATIENT'S DEATH HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123527 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8603172

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death