BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 20074180 · Received August 27, 2024

    Report

    Report Number
    2017233-2024-05265
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    May 30, 2024
    Report Date
    August 27, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE IS NOT AVAILABLE FOR RETURN. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. H6: CODE D12: ACCORDING TO THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: OCCLUSION (THROMBOSIS AND/OR STENOSIS) OF ENDOPROSTHESIS OR VESSEL. ¿RESULTS OF ENDOVASCULAR TREATMENT FOR VESSEL INJURY USING VIABAHN¿ NORIO HONGO. JOURNAL OF JAPANESE COLLEGE OF SURGEONS, 2024:49(3).P209. 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

    THE FOLLOWING ARTICLE WAS REVIEWED. ¿RESULTS OF ENDOVASCULAR TREATMENT FOR VESSEL INJURY USING VIABAHN¿ NORIO HONGO. JOURNAL OF JAPANESE COLLEGE OF SURGEONS, 2024:49(3).P209. OBJECT: TO INVESTIGATE A RESULT OF EVT USING GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WITH HEPARIN BIOACTIVE SURFACE FOR AN ARTERY INJURY AND A BLEEDING. MATERIAL AND METHOD: PATIENTS WHO WERE TREATED BY EVT USING VIABAHN DEVICE FOR THE ARTERY INJURY AND THE BLEEDING DURING JANUARY 2017 TO DECEMBER 2022 WERE INVESTIGATED RETROSPECTIVELY AND CONTINUATIVELY. TECHNICAL SUCCESS, CLINICAL SUCCESS, SYMPTOMATIC ISCHEMIA, PERIOPERATIVE COMPLICATION, RATE OF MORTALITY RELATED TO BLEEDING, RATE OF MORTALITY WITHIN 30 DAYS, RE-BLEEDING, ENDOLEAK AND PATENCY OF STENT GRAFT AT 1 MONTH, 3 MONTHS, 6 MONTHS, 12 MONTHS WERE EVALUATED. RESULT: NINETEEN PATIENTS (20 ARTERIES) WERE PERFORMED EVT USING VIABAHN DEVICE. THERE WERE SEVENTEEN MALES. AND AN AVERAGE AGE WAS 73.9 YEARS OLD. THE TECHNICAL SUCCESS RATE AND THE CLINICAL SUCCESS RATE WERE 100%. THE SYMPTOMATIC ISCHEMIA WAS NOT CONFIRMED, BUT ASYMPTOMATIC ARTERY OCCLUSION AT A PUNCTURE SITE IN A FEMORAL ARTERY WAS REPORTED IN ONE PATIENT. THE RATE OF MORTALITY RELATED TO BLEEDING WAS 0%. THE RATE OF MORTALITY WITHIN 30 DAYS WAS 95.0%. NO ENDOLEAK AND BLEEDING WERE OBSERVED DURING A FOLLOW-UP PERIOD (AVERAGE: 237.6 DAYS). THE PATENCY RATE OF THE STENT GRAFT AT 1 MONTH, 3 MONTHS, 6 MONTHS, 12 MONTHS WAS 83.6%, 75.2%, 62.7%, 62.7% RESPECTIVELY. CONCLUSION; EVT USING VIABAHN DEVICE FOR ARTERY INJURY WAS A FEASIBLE PROCEDURE WITH HIGH TECHNICAL SUCCESS, LESS COMPLICATION AND LOW RATE OF MORTALITY RELATED TO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940822 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other