BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4204203 · Received October 27, 2014

    Report

    Report Number
    2017233-2014-00555
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    July 19, 2013
    Report Date
    November 24, 2014
    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

    HOSPITALIZATION OCCURRED AS A RESULT OF THE REINTERVENTION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: ADDITIONAL DEVICES IMPLANTED: TGT3420/10371396; PXA280300/10386009; PXA280300/10386010 (DISTAL); PCX201000/10170217(CHIMNEY). RESULTS: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS CONCLUSION: ACCORDING TO THE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE THE GORE® TAG® THORACIC ENDOPROSTHESIS PROVIDES ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IN A REVIEW OF PUBLISHED LITERATURE, THE FOLLOWING FINDING WAS NOTED. IKOMA A, NAKAI M, SATO M, NISHIMURA Y, OKAMURA Y. EMBOLIZATION OF A PERIGRAFT GUTTER LEAK WITH COILS AND N-BUTYL CYANOACRYLATE THROUGH THE PSEUDOLUMEN USING A TRIPLE COAXIAL CATHETER SYSTEM AFTER ENDOVASCULAR AORTIC REPAIR WITH A CHIMNEY GRAFT. JOURNAL OF VASCULAR & INTERVENTIONAL RADIOLOGY 2014;25(10):1648-1650. A (B)(6)-YEAR-OLD WOMAN UNDERWENT SURGICAL REPLACEMENT OF THE ASCENDING AORTA AND INNOMINATE ARTERY FOR AN ACUTE AORTIC DISSECTION (STANFORD TYPE A). FOLLOW-UP COMPUTED TOMOGRAPHY (CT) 13 YEARS LATER SHOWED EXTENSIVE EXPANSION OF A RESIDUAL PSEUDOLUMEN THAT EXTENDED FROM THE AORTIC ARCH TO THE DESCENDING AORTA. THE PREOPERATIVE DIAMETER OF THE DISTAL AORTIC ARCH INCREASED FROM 52 MM TO 63 MM DURING THE FOLLOW-UP PERIOD. A DEBRANCHING PROCEDURE WITH A CHIMNEY GRAFT WAS PLANNED. AFTER AXILLOAXILLARY BYPASS, AXILLARY TO CAROTID BYPASS SURGERY AND LIGATION OF THE LEFT COMMON CAROTID ARTERY WERE CARRIED OUT, THE CHIMNEY PROCEDURE WAS PERFORMED. AN EXCLUDER LEG STENT-GRAFT (LARGE CONTRALATERAL LEG 20MM/9.5CM) WAS USED IN THE INNOMINATE ARTERY. THIS CHIMNEY GRAFT WAS ADVANCED TO THE INNOMINATE ARTERY VIA THE RIGHT BRACHIAL ARTERY. THEN A TAG ENDOPROSTHESIS WAS ADVANCED THROUGH THE RIGHT FEMORAL ARTERY. BOTH STENT GRAFTS WERE DEPLOYED SIMULTANEOUSLY. THE ORIGIN OF THE LEFT SUBCLAVIAN ARTERY, BRANCHING FROM A PSEUDOLUMEN, WAS OCCLUDED WITH DETACHABLE COILS TO PREVENT TYPE II ENDOLEAKS. NO ENDOLEAKS WERE DETECTED AFTER THE PROCEDURE. SIX MONTHS AFTER THE PROCEDURE A PERIGRAFT GUTTER LEAK AND EXPANSION OF THE PSEUDOLUMEN WAS SEEN ON CTA. A REINTERVENTION PROCEDURE WAS CARRIED OUT WHEREBY THE RIGHT CELIAC ARTERY WAS CATHETERIZED AND A TRIPLE COAXIAL CATHETER SYSTEM (TCCS) WAS ADVANCED TO THE PSEUDOLUMEN OF THE DESCENDING AORTA AND THEN TO THE TRUE LUMEN IN THE AORTIC ARCH. A SECOND CATHETER WAS ADVANCED COAXIALLY THROUGH THE FIRST CATHETER TO REACH THE PERIGRAFT GUTTER. THE GUTTER WAS EMBOLIZED WITH DETACHABLE COILS AND N-BUTYL CYANOACRYLATE (NBCA). THERE WERE NO PROCEDURAL COMPLICATIONS. SIX MONTHS AFTER THE REINTERVENTION A CTA FOLLOW-UP SHOWED NO EVIDENCE OF ENDOLEAK AND NO EXPANSION OF THE PSEUDOLUMEN.

    Description of Event or Problem · 1

    DATE OF INTERVENTION: (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682254 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9423585

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R