BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS

    MDR report key: 6939712 · Received October 11, 2017

    Report

    Report Number
    2017233-2017-00534
    Event Type
    Injury
    Date Received
    October 11, 2017
    Date of Event
    October 26, 2015
    Report Date
    November 23, 2017
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD THE LITERUTURE AS ATTACHMENT. (B)(4) ADDITIONAL INFORMATION ABOUT THIS EVENT WAS REQUESTED BUT COULD NOT BE OBTAINED. WITHOUT ADDITIONAL INFORMATION IT IS IMPOSSIBLE TO FURTHER INVESTIGATE THIS EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). NO TESTING METHODS WERE PERFORMED SINCE NO PRODUCT INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    IN REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED: HUNG-LUNG HSU, CHEN-MING HUANG, YIN-YIN CHEN, FU-CHIEN HSIEH,AND JER-SHEN CHEN, ¿THE SANDWICH TECHNIQUE WITH BODY FLOSSING WIRE TO REVASCULARIZE LEFT SUBCLAVIAN ARTERY IN THORACIC ENDOVASCULAR AORTIC REPAIR¿, ANNALS OF VASCULAR SURGERY 2017; 39: 152¿159, HTTP://DX.DOI.ORG/10.1016/J.AVSG.2016.04.016. FROM APRIL 2014 TO APRIL 2015, 20 CONSECUTIVE PATIENTS (14 MALES AND 6 FEMALES, MEAN AGE 61.4) RECEIVING TEVAR FOR ACUTE OR CHRONIC THORACIC AORTIC PATHOLOGIES WHICH NEED COVERING THE LSA FOR ADEQUATE PROXIMAL LANDING WERE INCLUDED. ALL PATIENTS WERE IMPLANTED WITH GORE® VIABAHN® ENDOPROSTHESIS IN THE LEFT SUBCLAVIAN ARTERY AS PERISCOPE GRAFTS, 15 PATIENTS WITH ONLY ONE GRAFT AND FIVE PATIENTS WITH MORE THAN ONE GRAFT. SEVEN OF 20 PATIENTS WERE IMPLANTED WITH GORE® VIABAHN® ENDOPROSTHESIS IN THE LEFT COMMON CAROTID ARTERY (LCCA) AS CHIMNEY ENDOGRAFTS. TOTAL 19 PATIENTS HAD PATENT SANDWICHED GRAFTS. IT WAS STATED THAT THE PATENCY RATE OF THE SANDWICHED PERISCOPE GRAFT IN THE THORACIC AORTA WAS 95% AT A MEAN FOLLOW-UP OF 9.7 MONTHS. THE ONLY ONE (5%) OCCLUDED SANDWICHED PERISCOPE GRAFT WAS FOUND IN A (B)(6) FEMALE WITH CHRONIC STERNAL WOUND INFECTION AND RAPID EXPANSION OF RESIDUAL DESCENDING AORTIC DISSECTION AT 12-MONTH FOLLOW-UP AFTER REINTERVENTION FOR A TYPE IA ENDOLEAK. THIS LSA GRAFT MIGHT BE COMPRESSED OR KINKED DURING THE SECONDARY PROCEDURE BY THE KISSING BALLOON TECHNIQUE OVER THE LCCA CHIMNEY GRAFT AND THE EXTENDED PROXIMAL AORTIC ENDOGRAFT. NO NEUROLOGICAL DEFICIT OR LEFT UPPER LIMB ISCHEMIA WAS NOTED IN THE PATIENT AND THE OCCLUDED GRAFT WAS NOT ADDRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720366 GORE® VIABAHN® ENDOPROSTHESIS NIP PFV W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other