BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5510676 · Received March 18, 2016

    Report

    Report Number
    2017233-2016-00258
    Event Type
    Death
    Date Received
    March 18, 2016
    Date of Event
    March 12, 2016
    Report Date
    March 12, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: THE PATIENT'S MEDICATIONS INCLUDE: ASPIRIN, VITAMIN D, NORCO, TOPROL, SYNTHROID AND OXYCONTIN. ADDITIONAL DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: TGU454515/14090191 AND TGU454510/14090127. (B)(4). THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE STATES THAT COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO BRANCH VESSEL OCCLUSION OR OBSTRUCTION, AORTIC RUPTURE, PERSISTENT FALSE LUMEN FLOW, DISSECTION, PERFORATION, OR RUPTURE OF THE AORTIC VESSEL & SURROUNDING VASCULATURE, ENDOLEAK, BLEEDING (PROCEDURAL AND POST-TREATMENT), CARDIAC (E.G., ARRHYTHMIA, MYOCARDIAL INFARCTION, CONGESTIVE HEART FAILURE, HYPOTENSION OR HYPERTENSION), AND DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE PATIENT UNDERWENT TREATMENT OF AN ACUTE TYPE B DISSECTION AND CONTAINED RUPTURE OF THE THORACIC AORTA WITH THREE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. INTRA-OPERATIVE ANGIOGRAPHY IDENTIFIED THE PRIMARY ENTRY TEAR ~1 CM DISTAL TO THE LEFT SUBCLAVIAN ARTERY (LSA). REPORTEDLY, IN AN EFFORT TO OBTAIN AN ADDITIONAL 1.5 CM OF SEAL, THE PHYSICIAN ELECTED TO IMPLANT THE TAG DEVICE (TGU343415) DISTAL TO THE LEFT COMMON CAROTID ARTERY (LCCA) WITH INTENTIONAL COVERAGE OF THE LSA. ADDITIONALLY, TO ADDRESS THE RUPTURE, THE PHYSICIAN PLANNED TO COVER THE DESCENDING AORTA DISTALLY FROM THE LCCA TO THE CELIAC ARTERY. FIRST, A TAG DEVICE (TGU454515) WAS IMPLANTED DISTALLY, THEN THE TAG DEVICE (TGU343415) WAS IMPLANTED IN THE MOST PROXIMAL POSITION. FINALLY, AN ADDITIONAL TAG DEVICE (TGU454510) WAS IMPLANTED AS A BRIDGE BETWEEN THE TWO DEVICES. REPORTEDLY, SUFFICIENT OVERLAP WAS OBTAINED, WITH A REPORTED 4-5 CM OVERLAP BETWEEN ALL DEVICES. REPORTEDLY, TOUCH UP BALLOONING WAS PERFORMED WITHIN THE OVERLAP AREAS UTILIZING A GORE® TRI-LOBE BALLOON CATHETER (BCL2645) ACCORDING TO STANDARD PROTOCOL AND IN AN UNHURRIED FASHION. IT WAS REPORTED THAT DURING BALLOONING THE SEPTUM RUPTURED RESULTING IN A NOTICEABLE DROP IN THE PATIENT'S BLOOD PRESSURE. MEDICATION WAS ADMINISTERED AND THE PATIENT RECOVERED. HOWEVER, DURING FINAL BALLOONING REPORTEDLY THE PATIENT'S BLOOD PRESSURE KEPT DROPPING AND REBOUNDING. IMAGING WAS AGAIN PERFORMED AND BLOOD FLOW WAS SEEN AT THE PROXIMAL END OF THE TAG DEVICE (TGU343415). IT WAS REPORTED, THE BLOOD FLOW CONTINUED PAST THE GRAFT AND INTO THE LSA WITH PERSISTENT FILLING OF THE PRIMARY ENTRY TEAR. TO ADDRESS THE ISSUE, THE PHYSICIAN ELECTED TO PLACE A 14 MM AMPLATZER PLUG INTO THE LSA. REPORTEDLY, AT THIS POINT IN THE PROCEDURE THE PATIENT WENT INTO ACUTE CARDIAC ARREST AND ASYSTOLE. CHEST COMPRESSIONS WERE PERFORMED AND SIX UNITS OF BLOOD PRODUCTS WERE ADMINISTERED. HOWEVER, AFTER 20 MINUTES OF CONTINUED CARDIOPULMONARY RESUSCITATION (CPR) IT WAS REPORTED THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166832 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 14639028

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death