BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)

    MDR report key: 8008683 · Received October 26, 2018

    Report

    Report Number
    2017233-2018-00648
    Event Type
    Injury
    Date Received
    October 26, 2018
    Date of Event
    July 25, 2017
    Report Date
    October 4, 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. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES. ADDITIONALLY, PER IFU, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK AND ANEURYSM ENLARGEMENT.

    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, (B)(4)) WAS POSITIONED IN THE TARGET SAB OVER A ROSEN (COOK MEDICAL, (B)(4)) 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, TWO TYPE II ENDOLEAKS WERE REPORTED THAT WERE TREATED WITH COIL EMBOLISATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848923 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