BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 17816702 · Received September 26, 2023

    Report

    Report Number
    2017233-2023-04296
    Event Type
    Death
    Date Received
    September 26, 2023
    Date of Event
    August 29, 2022
    Report Date
    December 21, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. SECTION H6: CODE D12-THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), FOR THE APPROPRIATE REGION AND TIME-PERIOD, WAS REVIEWED WITH RESPECT TO THE COMPLAINT DETAIL, AND THERE ARE APPLICABLE STATEMENTS. THE IFU STATES THE FOLLOWING: "POSSIBLE ADVERSE EVENTS AND COMPLICATIONS THAT MAY OCCUR WITH THE USE OF THIS DEVICE OR IN ANY ENDOVASCULAR PROCEDURE AND REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: OCCLUSION (THROMBOSIS AND/OR STENOSIS) OF ENDOPROSTHESIS OR VESSEL."

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. C1: HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. H6 CODE B14: A REVIEW OF THE MANUFACTURING RECORDS COULDN'T BE PERFORMED BECAUSE THE SERIAL NUMBER IS UNKNOWN. H3 AND H6 CODE B20: THE DEVICE REMAINS IMPLANTED IN THE PATIENT. THEREFORE A DEVICE EVALUATION COULD NOT BE PERFORMED. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    REPORTEDLY ON (B)(6) 2019, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF A THORACOABDOMINAL ANEURYSM I WHICH WAS TREATED WITH A FENESTRATED AND BRANCHED STENT GRAFT COMPONENT (ZENITH® T-BRANCH® THORACOABDOMINAL ENDOVASCULAR GRAFT, COOK MEDICAL). DURING THE PROCEDURE PLANNING, IT WAS DETERMINED THAT THE CELIAC TRUNK, SUPERIOR MESENTERIC ARTERY, RIGHT AND LEFT RENAL ARTERY WILL BE INCORPORATED IN THE FENESTRATED AND BRANCHED ENDOGRAFT. TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VIABAHN® VBX DEVICE) WERE IMPLANTED IN THE LEFT AND RIGHT RENAL ARTERY. REPORTEDLY, THE WHOLE PROCEDURE WAS UNEVENTFUL, AORTIC ACCESS WAS SUCCESSFULLY GAINED, DEVICE DEPLOYED AS INTENDED, CATHETERS WERE SUCCESSFULLY REMOVED AND THE PATENCY OF THE DEVICES WERE CONFIRMED AT THE END OF THE PROCEDURE. NO MAJOR STROKE WAS EXPERIENCED, NO GRADE 3 PARAPLEGIA AND THE PATIENT DIDN'T UNDERGO DIALYSIS AFTER THE PROCEDURE AND AN ADDITIONAL ANTIPLATELET MEDICATION WAS ADMINISTERED TO THE PATIENT DURING THE PROCEDURE. ACCORDING TO REPORTS, ON (B)(6) 2019, AN ADVERSE EVENT RECORDED AS "WOUND INFECTION, PRESUMABLY SYSTEMIC INFLAMMATORY RESPONSE SYNDROME" WAS DISCOVERED AND IT WAS INDICATED TO BE PROCEDURE RELATED. A MEDICATION WAS ADMINISTERED AND THE PATIENT RECOVERED WITHOUT A SEQUELAE. REPORTEDLY ON (B)(6) 2022, DURING AN ADVERSE EVENT TERMED " STENT IN BOTH RENAL ARTERIES OCCLUDED WHICH REQUIRED DIALYSIS. DURING DIALYSIS AN INSULT AND LOSS OF STRENGTH IN LEGS OCCURRED. LATER A PARTIAL SPINAL CORD'' WAS DISCOVERED. REPORTEDLY THE OUTCOME OF THE ADVERSE EVENT WAS RECORDED AS FATAL SINCE IT LEAD TO DEATH, HOWEVER THE PRIMARY RELATIONSHIP WAS RECORDED AN UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973428 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other