BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2575124 · Received May 8, 2012

    Report

    Report Number
    2017233-2012-00301
    Event Type
    Death
    Date Received
    May 8, 2012
    Date of Event
    April 24, 2012
    Report Date
    April 24, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. PER THE GORE CONFORMABLE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE THE SAFETY AND EFFECTIVENESS OF THE GORE TAG THORACIC ENDOPROSTHESIS HAVE NOT BEEN EVALUATED IN THE FOLLOWING PT ETIOLOGIES: ACUTE AND CHRONIC DISSECTIONS. ATTEMPTS TO ACQUIRE INFO REQUIRED FOR THIS FORM WERE MADE BY GORE. PLEASE NOTE ADD¿L DEVICES IMPLANTED AND RELATED TO THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ON AN UNK DATE, THE PT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT (DEVICE LOT/SERIAL NUMBER UNK) TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE DEVICE LANDED BELOW THE LEVEL OF THE RENAL ARTERIES. ON (B)(6) 2012, THE PT WAS IMPLANTED WITH A GORE CONFORMABLE TAG THORACIC ENDOPROSTHESIS (B)(4) TO TREAT A THORACIC AORTIC ANEURYSM. ON (B)(6) 2012, THE PT PRESENTED TO THE HOSPITAL WITH PAIN IN THEIR ABDOMINAL AREA. A COMPUTED TOMOGRAPHY REVEALED A POSSIBLE TEAR DISTAL TO THE PREVIOUSLY IMPLANTED GORE CONFORMABLE TAG THORACIC ENDOPROSTHESIS. THE SAME DAY, THE PT WAS IMPLANTED WITH TWO GORE CONFORMABLE TAG THORACIC ENDOPROSTHESIS (B)(4) TO TREAT THE TEAR. THE RENAL ARTERIES, CELIAC ARTERY AND THE SUPERIOR MESENTERIC ARTERY WERE INTENTIONALLY COVERED BY THE GRAFTS, HOWEVER, THE PHYSICIAN PERFORMED A THORACIC-ABDOMINAL SURGERY USING THE VASCULAR SURGICAL GRAFT AND FOUR GORE HYBRID VASCULAR GRAFTS TO HELP MAINTAIN BLOOD FLOW TO THE RENAL ARTERIES, CELIAC ARTERY AND THE SUPERIOR MESENTERIC ARTERY. IT WAS REPORTED THAT THE VASCULAR GRAFT WAS SEWN TO THE TOP OF THE EXCLUDER GRAFT AND LIMBS OF THE BIFURCATED VASCULAR GRAFT AND THE FOUR HYBRID GRAFTS WERE POINTING UP TOWARDS THE RENAL AND MESENTERIC ARTERIES. A DACRON GRAFT WAS SEWN INTO THE VASCULAR GRAFT SO IT COULD BE USED AS A CONDUIT FOR THE 22FR SHEATH. IT WAS REPORTED THAT THE PT LOST A LARGE AMOUNT OF BLOOD DURING THE PROCEDURE AND RECEIVED MULTIPLE BLOOD TRANSFUSIONS. IT WAS REPORTED THAT THE PT¿S BLOOD PRESSURE DROPPED DURING THE SURGICAL PROCEDURE AND DIED ON THE TABLE DUE TO THE LARGE AMOUNT OF BLOOD LOSS. CHEST COMPRESSIONS WERE NOT ABLE TO BE PERFORMED DUE TO THE PT LAYING ON THEIR SIDE FOR THE SURGICAL PROCEDURE. THE PHYSICIAN STATED THAT THE BLOOD LOSS COULD HAVE BEEN ATTRIBUTED TO ANOTHER DISSECTION OR TEAR THAT WAS NOT REVEALED ON THE COMPUTED TOMOGRAPHY. IT WAS ALSO REPORTED THAT THE PT WAS PLACED ON A VENTILATOR ON (B)(6) 2012, PRIOR TO THE PROCEDURE. THE REASON FOR THE VENTILATOR PRIOR TO THE PROCEDURE IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS MIH/ SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES,INC 9741796

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death LISINOPRIL| NIPRIDE| BACTROBAN| ACETAMINOPHEN| DUONEB| PEPCID| DILADID| ZOFRAN| METEPROLOL| PROPOFOL| PERIDEX