BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3161834 · Received June 7, 2013

    Report

    Report Number
    2017233-2013-00362
    Event Type
    Death
    Date Received
    June 7, 2013
    Date of Event
    June 14, 2007
    Report Date
    May 24, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE TAG THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO VASCULAR TRAUMA (E.G., ILIO-FEMORAL VESSEL DISSECTION, BLEEDING, RUPTURE), NEUROLOGIC DAMAGE, LOCAL OR SYSTEMIC (E.G., STROKE), AND DEATH. PLEASE NOTE: THE PUBLISHED DATE OF THE ARTICLE IS (B)(6) 2007. SINCE NO OTHER DATES WERE PROVIDED IN THE CASE, THE DATE OF EVENT IN THIS FORM WILL BE (B)(6) 2007.

    Description of Event or Problem · 1

    IN REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED: W. ANTHONY LEE, MD, THOMAS D MARTIN, MD, PHILIP J. HESS, MD, THOMAS M. BEAVER, MD, AND THOMAS S. HUBER, MD, PHD, "MALDEPLOYMENT OF THE TAG THORACIC ENDOGRAFT", COPYRIGHT 2007 BY THE SOCIETY FOR VASCULAR SURGERY. THE PT WAS A (B)(6) WOMAN WHO HAD A 7.5 CM DISTAL ARCH THORACIC AORTIC ANEURYSM. PREOPERATIVE EVAL INCLUDED A CHEST-ABDOMEN-PELVIS COMPUTED TOMOGRAPHIC ANGIOGRAM AND A CAROTID DUPLEX EXAM. THERE WAS NO EVIDENCE OF ANY SIGNIFICANT OCCLUSIVE DISEASE OF THE COMMON CAROTID ARTERIES OR THE BIFURCATION. SHE UNDERWENT A RIGHT CAROTID-TO-LEFT SUBCLAVIAN ARTERY BYPASS WITH REIMPLANTATION OF THE LEFT CAROTID ARTERY TO GAIN AN ADDITIONAL PROXIMAL LANDING ZONE, WITH A PLAN TO PERFORM A TAG STENT GRAFT REPAIR AS A SINGLE STAGE UNDER GENERAL ANESTHESIA. A 22F 35-CM INTRODUCER SHEATH WAS ADVANCED TO THE PROXIMAL ABDOMINAL AORTA, AND A 31 X 100 MM DEVICE WAS INSERTED AND POSITIONED IN THE TRANSVERSE ARCH AFTER CONTROL ANGIOGRAPHY. THE DEPLOYMENT STRING WAS PULLED, BUT THE PROXIMAL END OF THE DEVICE FAILED TO DEPLOY. THE STRING CAME OUT INTACT WITHOUT ANY EVIDENCE OF A BREAK, AND THERE WAS NO RESISTANCE OR OTHER TACTILE CUES THAT INDICATED ANY IRREGULARITY. INITIAL ATTEMPTS TO GENTLY TEASE THE LEADING OLIVE TIP THROUGH THE UNDEPLOYED PROXIMAL END RESULTED IN CAUDAL MOVEMENT OF THE DEVICE INTO THE MID DESCENDING THORACIC AORTA AND PARTIAL INTUSSUSCEPTION OF THE PROXIMAL END INTO THE ENDOGRAFT. THE ENTIRE DELIVERY CATHETER WAS ESSENTIALLY TRAPPED BY THE NOSECONE, WHICH COULD NOT BE RETRACTED THROUGH THE UNDEPLOYED DEVICE, AND THE PT HAD A PERIOD OF NEAR-TOTAL THORACIC AORTIC OCCLUSION. THE STENT GRAFT RODE FREELY OVER THE DELIVERY CATHETER, AND THE DISTAL OLIVE WAS USED TO PUSH OUT THE INTUSSUSCEPTION AND "DRAG" THE STENT GRAFT BACK UP TO THE PROXIMAL DESCENDING THORACIC AORTA. THROUGH THE CONTRALATERAL FEMORAL ACCESS, AN 0.018-INCH GUIDEWIRE WAS INTRODUCED INTO THE OPEN DISTAL END OF THE ENDOGRAFT AND PASSED THROUGH THE SPACE BETWEEN THE CONSTRAINED END OF THE DEVICE AND THE HYPOTUBE. A 4-MM BALLOON WAS USED TO INITIALLY DILATE THE OPENING, WHICH ALLOWED EXCHANGE TO AN 0.035-INCH GUIDEWIRE AND SERIAL DILATION UP TO AN 8-MM ANGIOPLASTY BALLOON. THERE WAS TIGHT WAISTING OF THE BALLOON UNTIL AT APPROXIMATELY 12 ATM, WHEN THE CONSTRAINING LOOP WAS BROKEN AND THE END WAS FULLY OPENED. THE DELIVERY CATHETER WAS REMOVED, AND TWO ADDITIONAL TAG DEVICES WERE REQUIRED TO COMPLETE THE PROCEDURE. AS THE DEVICE INTRODUCER SHEATH WAS BEING WITHDRAWN, THE ILIAC ARTERY BECAME DISRUPTED, THUS NECESSITATING TEMPORARY BALLOON CONTROL, RETROPERITONEAL EXPLORATION, AND AN ILIOFEMORAL BYPASS. THE ENTIRE PROCEDURE TOOK APPROXIMATELY 5 HRS, WITH A FLUOROSCOPY TIME OF 67 MINUTES, 160 ML OF CONTRAST, AND BLOOD LOSS OF 2000 ML. AFTER SURGERY, THE PT DID NOT WAKE UP FROM ANESTHESIA, AND A BRAIN MAGNETIC RESONANCE IMAGE REVEALED MULTIPLE BIHEMISPHERIC INFARCTS IN THE ANTERIOR AND POSTERIOR CIRCULATIONS AND WATERSHED TERRITORIES. A COMPUTED TOMOGRAPHIC ANGIOGRAM SHOWED THAT THE STENT GRAFTS WERE WELL POSITIONED, AND THE ANEURYSM WAS COMPLETELY EXCLUDED WITHOUT AN ENDOLEAK, AND ALL THE BYPASS GRAFTS WERE PATENT. DESPITE USUAL SUPPORTIVE MEASURES, SHE DID NOT RECOVER ANY MEANINGFUL NEUROLOGIC FUNCTION AND EVENTUALLY DIED ON POSTOPERATIVE DAY 68. ALTHOUGH THE EXACT ETIOLOGY OF THE PT'S STROKE COULD NOT BE ASCERTAINED, THE LIKELY CAUSES INCLUDE THROMBOEMBOLI FROM THE EXTENSIVE MANIPULATION OF THE TAG DEVICE IN THE ARCH AFTER IT FAILED TO DEPLOY AND THE TRANSIENT INTRAOPERATIVE HYPOTENSION FROM THE ILIAC DISRUPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252440 GORE TAG THORACIC ENDOPROSTHESIS MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death