BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 15901852 · Received December 2, 2022

    Report

    Report Number
    2017233-2022-03525
    Event Type
    Injury
    Date Received
    December 2, 2022
    Date of Event
    January 1, 2021
    Report Date
    December 1, 2022
    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

    A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS COMPLAINT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED AND WAS, THEREFORE, NOT AVAILABLE FOR ANALYSIS. NO CLINICAL IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE WERE RETURNED FOR EVALUATION. CAUSE OF THE REPORTED EVENT CANNOT BE ESTABLISHED BASED ON EVALUATION OF THE INFORMATION REPORTED TO GORE. FURTHER INFORMATION REGARDING THIS EVENT WAS REQUESTED BY GORE, BUT NO FURTHER INFORMATION HAS BEEN REPORTED, THEREFORE THIS INVESTIGATION IS CONSIDERED COMPLETE. CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. AS THE FOLLOWING DEVICE WAS USED AS AN OVERLAPPING SYSTEM THEY WILL BE INCLUDED IN THIS REPORT: GORE® VIABAHN® ENDOPROSTHESIS (B)(4) GORE® VIABAHN® ENDOPROSTHESIS WERE OVERLAPPED AND IMPLANTED IN SAME ANATOMICAL LOCATION. 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 LITERATURE ARTICLE WAS REVIEWED: TITLE: A CASE STUDY OF VIABAHN STENT PLACEMENT FOR RUPTURED PSEUDOANEURYSM AFTER PANCREATICODUODENECTOMY SOURCE: OFFICIAL JOURNAL OF JAPANESE SOCIETY OF GASTROENTEROLOGICAL SURGERY 2022: 77 P.S15-5. THE PATIENT WAS A 68-YEAR-OLD MALE. (B)(6) 2020, THE PATIENT UNDERWENT PANCREATICODUODENECTOMY (PD) FOR DUODENAL CANCER. (B)(6) 2020 (ON THE THIRD POSTOPERATIVE DAY), A HIGH DRAIN AMY OF 12470 U/L WAS OBSERVED, AND THE PATIENT WAS DIAGNOSED AS A PANCREATIC EFFUSION OF ISGPR CRITERIA GRADE B, AND DRAINAGE TREATMENT WAS CONTINUED. (B)(6) 2020 (ON THE 39TH POSTOPERATIVE DAY), BLEEDING AND DRAIN HEMORRHAGE WERE OBSERVED, BUT CONTRAST-ENHANCED CT SHOWED NO OBVIOUS EXTRAVASATION. HEMOGRAM SHOWED IRREGULAR VASCULAR MORPHOLOGY OF COMMON HEPATIC ARTERY (CHA), AND A DIAGNOSIS OF RUPTURED CHA PSEUDOANEURYSM. TWO GORE® VIABAHN® ENDOPROSTHESES WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WERE IMPLANTED, AND HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS STARTED ON BAYASPIRIN AFTER THE IMPLANTATION. IN 2021 (FIVE MONTHS AFTER THE VIABAHN DEVICE IMPLANTATION), CT SHOWED THE VIABAHN DEVICE OCCLUSION, BUT HEPATIC BLOOD FLOW WAS MAINTAINED BY COLLATERAL VESSELS. THEREFORE, NO ADDITIONAL TREATMENT WAS PERFORMED. IN SUMMARY, THE VIABAHN DEVICE HAD A LANDING ZONE OF AT LEAST 2 CM AND THERE WAS NO RISK OF OCCLUSION OF A CRITICAL BRANCH, AND HEMOSTASIS WAS ACHIEVED WITH THE VIABAHN DEVICE. THE VIABAHN DEVICE OCCLUSION OCCURRED, BUT HEPATIC BLOOD FLOW WAS MAINTAINED, PROBABLY BECAUSE OF THE SLOW OCCLUSION. IN ADDITION, THE PHYSICIAN REPORTEDLY STATED: THE PATIENT'S CONDITION IS FINE. CONSIDERING THE RISK OF REBLEEDING, THE PATIENT WAS PRESCRIBED SINGLE AGENT BAYASPIRIN POSTOPERATIVELY. THE VIABAHN DEVICE OCCLUSION WAS SOMEWHAT PREDICTABLE, SO NO PROBLEM. 2203-A:-OTHER IS USED AS NO ADDITIONAL TREATMENT WAS PERFORMED SINCE HEPATIC BLOOD FLOW WAS MAINTAINED BY COLLATERAL VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966274 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization