BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 19652696 · Received July 1, 2024

    Report

    Report Number
    2017233-2024-05075
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 8, 2024
    Report Date
    July 17, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE WAS DISCARDED AT FACILITY. RETURN NOT POSSIBLE. 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 INSTRUCTION FOR USE (IFU), THE POTENTIAL ADVERSE EVENTS WITH THE USE OF DEVICE MAY INCLUDE BUT ARE NOT LIMITED TO: MIGRATION. HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. 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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION CONCLUSIONS CODE UPDATED FROM D12 "KNOWN INHERENT RISK OF DEVICE" TO D1001 "ADVERSE EVENT RELATED TO PROCEDURE. THE DEVICE MIGRATION AFTER DEPLOYMENT IS ATTRIBUTED TO THE USE OF NON-GORE BALLOON (BALLOON SLIPPING DURING THE PROCEDURE).

    Description of Event or Problem · 0

    ON UNKNOWN DATE, THIS PATIENT HAD AN ARTERIOVENOUS GRAFT (AVG) IMPLANTED TO THE CEPHALIC VEIN OF THE RIGHT UPPER ARM USING 5MM SIZED VECTRA VASCULAR ACCESS GRAFT (GOODMAN CO.,LTD). 10 DAYS AFTER THE PROCEDURE, THE VENOUS ANASTOMOSIS SITE WAS FOUND TO HAVE OCCLUDED, THEREFORE, A GORE® VIABAHN® ENDOPROSTHESIS (SIZE UNKNOWN) WAS IMPLANTED TO TREAT THE OCCLUSION. ON AN UNKNOWN DATE, THE VENOUS ANASTOMOSIS SITE WAS FOUND TO HAVE THROMBOSED. A THROMBECTOMY WAS PERFORMED USING A 4FR FOGARTY BALLOON CATHETER. AS IT WAS DIFFICULT TO COMPLETELY REMOVE THROMBI, ANOTHER GORE® VIABAHN® ENDOPROSTHESIS (JHJR060702J) WAS IMPLANTED TO TREAT THE RESIDUAL STENOSIS. THE OVERLAP LENGTH OF THE JHJR060702J AND PREVIOUSLY IMPLANTED VIABAHN WAS ABOUT 1CM. AFTER PERFORMING ANOTHER FOGARTY THROMBECTOMY, THE JHJR060702J WAS POST-DILATED USING 6MM×10CM ATHLETIS¿ BALLOON DILATATION CATHETER (BOSTON SCIENTIFIC CORPORATION), DURING WHICH THE BALLOON SLIPPED AND THE JHJR060702J WAS DISCONNECTED. THE JHJR060702J MIGRATED AND STOPPED AT THE SUBCLAVIAN VEIN. NO FURTHER TREATMENT WAS PERFORMED, AND THE PHYSICIAN COMPLETED THE PROCEDURE. ABOUT 1 MONTH AFTER THE PROCEDURE, IT WAS CONFIRMED THAT JHJR060702J HAD FURTHER MIGRATED TO THE PULMONARY ARTERY. THE PATIENT IS ASYMPTOMATIC, SO NO TREATMENT IS PERFORMED AT THIS MOMENT. THE PATIENT IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759618 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male