BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)

    MDR report key: 8008883 · Received October 26, 2018

    Report

    Report Number
    2017233-2018-00649
    Event Type
    Injury
    Date Received
    October 26, 2018
    Date of Event
    July 25, 2017
    Report Date
    October 2, 2018
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE THE INCIDENT OCCURRED IS UNKNOWN, SO THE DATE OF PUBLICATION OF THE ARTICLE WAS USED AS THE INCIDENT DATE.

    Description of Event or Problem · 1

    WITHIN THE ARTICLE ¿MID-TERM RESULTS OF CHIMNEY AND PERISCOPE GRAFTS IN SUPRA-AORTIC BRANCHES IN HIGH RISK PATIENTS¿, PUBLISHED BY F. PECORARO ET AL, IN THE EUROPEAN SOCIETY FOR VASCULAR SURGERY, CIRCULATED ON JULY 25, 2017, THE ARTICLE RESULTS INDICATE THE FOLLOWING: A RETROSPECTIVE ANALYSIS, FROM OCTOBER 2009 TO MAY 2014, OF PATIENTS WITH ANEURYSMS REQUIRING THORACIC ENDOVASCULAR ANEURYSM REPAIR (TEVAR) WITH ZONE 0/1/2 PROXIMAL LANDING IN ASSOCIATION WITH AT LEAST ONE CHIMNEY AND PERISCOPE GRAFTS (CPG) IN THE SUPRA-AORTIC BRANCHES (SAB), WAS CONDUCTED. 26 PATIENTS WERE TREATED ELECTIVELY AND 15 NON-ELECTIVELY. 59 SABS WERE TREATED WITH THE CPG TECHNIQUE: IN 29 CASES A SINGLE CPG WAS USED, IN 8 A DOUBLE, IN 2 A TRIPLE, AND IN 4 A QUADRUPLE. THE PROXIMAL LANDING WAS IN ZONE 0 IN 49% OF PATIENTS, ZONE 1 IN 17%, AND ZONE 2 IN 34%. FOR THE CPG TECHNIQUE A STENT GRAFT (HEMOBAHN OR VIABAHN; W.L. GORE & ASSOCIATES, FLAGSTAFF, AZ, USA) WAS POSITIONED IN THE TARGET SAB OVER A ROSEN (COOK MEDICAL, IN, USA) OR AMPLATZ (BOSTON SCIENTIFIC) WIRE WITH THE SUPPORT OF A SHEATH. GENERALLY, FIRST THE CPG STENT GRAFTS, THEN THE AORTIC STENT GRAFT (TAG; W.L. GORE & ASSOCIATES) WERE DEPLOYED. AFTER DEPLOYMENT OF THE CPGS, SHEATHS WERE REINSERTED FOR STABILISATION AND FOR EVENTUAL PROXIMAL AND/OR DISTAL STENT GRAFT EXTENSION. THE AORTIC STENT GRAFT WAS PARKED AND DEPLOYED APPROXIMATELY 1 CM DISTAL TO THE CPG POSITION. CPGS WERE OVERSIZED 1-2 MM WITH RESPECT TO THE TARGET SAB. THE CPGS AND THE AORTIC STENT GRAFT WERE MOULDED USING THE KISSING BALLOON TECHNIQUE. SINCE 2015 ALL PARALLEL GRAFTS HAVE BEEN PRIMARILY REINFORCED BY A CORRESPONDING WALLSTENT (BOSTON SCIENTIFIC) RELINING THE ENTIRE LENGTH OVER WHICH THE CPG COULD BE COMPRESSED WHEN RUNNING PARALLEL TO THE AORTA. TECHNICAL SUCCESS WAS ACHIEVED IN ALL BUT 2 CASES (95%). AMONG OTHER ENDOLEAKS THAT WERE REGISTERED DURING FOLLOW-UP, ONE TYPE IB ENDOLEAK WAS MENTIONED THAT WAS TREATED WITH COIL EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849112 AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention