BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 8342459 · Received February 15, 2019

    Report

    Report Number
    2017233-2019-00083
    Event Type
    Injury
    Date Received
    February 15, 2019
    Date of Event
    January 29, 2019
    Report Date
    April 25, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIO
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMBINATION PRODUCT WAS CHANGED TO "YES".

    Additional Manufacturer Narrative · 0

    CODE-213: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. A POST-OPERATIVE CT SERIES DATED 2/4/2019 WAS PROVIDED. THERE IS AN AREA IN THE RIGHT RENAL ARTERY DISTAL TO THE DEVICE THAT COULD BE DISSECTED, HOWEVER, ONE CANNOT BE CERTAIN.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT PRESENTED WITH A TYPE IIIC ENDOLEAK AFTER A PREVIOUS FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) WITH A LIFESTREAM® BALLOON EXPANDABLE VASCULAR COVERED STENT (BARD PERIPHERAL VASCULAR, INC) IN THE RIGHT RENAL ARTERY. IT WAS STATED THAT THE PROXIMAL PART OF THIS STENT (AORTIC SIDE) WAS STENOTIC. THEREFORE IT WAS DECIDED TO PERFORM A SURGICAL RETROGRADE ACCESS TO THE RENAL ARTERY IN ORDER TO ENGAGE THE PREVIOUS STENT-GRAFT. TO SOLVE THE TYPE IIIC ENDOLEAK ORIGINATING BETWEEN A PREVIOUS IMPLANTED FENESTRATED ABDOMINAL ENDOPROSTHESIS AND ANOTHER ENDOPROSTHESIS IN THE RENAL ARTERY A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WAS USED AS A BRIDGING DEVICE. THE VBX WAS SUCCESSFULLY NAVIGATED TO THE PLANNED LOCATION AND DEPLOYED AS INTENDED. DURING THE PROCEDURE AN IATROGENIC DISSECTION OF THE RIGHT RENAL ARTERY DISTAL TO THE VBX WAS IDENTIFIED. IT WAS STATED THAT THE INSERTION OF THE INTRODUCER SHEATH (MICROPUNCTURE® PEDAL INTRODUCER ACCESS SET, COOK MEDICAL) INTO THE RENAL ARTERY MAY HAVE LED TO THE DISSECTION. THE RENAL ARTERY DISSECTION WAS RESOLVED IN A "BAIL OUT" STENTING PROCEDURE WITH A GORE® TIGRIS® VASCULAR STENT. ACQUIRED IMAGES OF INTRA-PROCEDURAL DISSECTION AND COMPUTERTOMOGRAPHIC ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2019 DEMONSTRATED THE POSTOPERATIVE PATENCY OF BOTH, VBX AND RIGHT RENAL ARTERY. IT WAS STATED THAT AN ESTIMATED BLOOD LOSS OF 4000 ML OCCURRED DURING THE PROCEDURE LEADING TO A HYPOVOLEMIC SHOCK OF THE PATIENT. THIS COULD NOT BE FINALLY RESOLVED YET. THE PROGNOSIS OF THE PATIENT WAS UNCERTAIN. ON 14-MAR-2019 GORE WAS INFORMED THAT THE PATIENT HAS GONE BETTER AND IS GOING TO BE DISCHARGED IN NEXT DAYS WITHOUT PERMANENT DEFICITS.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT PRESENTED WITH A TYPE IIIC ENDOLEAK AFTER A PREVIOUS FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) WITH A LIFESTREAM® BALLOON EXPANDABLE VASCULAR COVERED STENT (BARD PERIPHERAL VASCULAR, INC) IN THE RIGHT RENAL ARTERY. IT WAS STATED THAT THE PROXIMAL PART OF THIS STENT (AORTIC SIDE) WAS STENOTIC. THEREFORE IT WAS DECIDED TO PERFORM A SURGICAL RETROGRADE ACCESS TO THE RENAL ARTERY IN ORDER TO ENGAGE THE PREVIOUS STENT-GRAFT. TO SOLVE THE TYPE IIIC ENDOLEAK ORIGINATING BETWEEN A PREVIOUS IMPLANTED FENESTRATED ABDOMINAL ENDOPROSTHESIS AND ANOTHER ENDOPROSTHESIS IN THE RENAL ARTERY A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WAS USED AS A BRIDGING DEVICE. THE VBX WAS SUCCESSFULLY NAVIGATED TO THE PLANNED LOCATION AND DEPLOYED AS INTENDED. DURING THE PROCEDURE AN IATROGENIC DISSECTION OF THE RIGHT RENAL ARTERY DISTAL TO THE VBX WAS IDENTIFIED. IT WAS STATED THAT THE INSERTION OF THE INTRODUCER SHEATH (MICROPUNCTURE® PEDAL INTRODUCER ACCESS SET, COOK MEDICAL) INTO THE RENAL ARTERY CONTRIBUTED OR MIGHT HAVE CONTRIBUTED TO THE DISSECTION. THE RENAL ARTERY DISSECTION WAS RESOLVED IN A "BAIL OUT" STENTING PROCEDURE WITH A GORE® TIGRIS® VASCULAR STENT. ACQUIRED IMAGES OF INTRA-PROCEDURAL DISSECTION AND COMPUTERTOMOGRAPHIC ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2019 DEMONSTRATED THE POSTOPERATIVE PATENCY OF BOTH, VBX AND RIGHT RENAL ARTERY. IT WAS STATED THAT AN ESTIMATED BLOOD LOSS OF 4000 ML OCCURRED DURING THE PROCEDURE LEADING TO A HYPOVOLEMIC SHOCK OF THE PATIENT. THIS COULD NOT BE FINALLY RESOLVED YET. THE PROGNOSIS OF THE PATIENT IS STILL UNCERTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139064 GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS STENT, ILIAC NIO W.L. GORE & ASSOCIATES 18515539

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other| R