BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABIL® BILIARY ENDOPROSTHESIS

    MDR report key: 17668639 · Received September 1, 2023

    Report

    Report Number
    3003910212-2023-01494
    Event Type
    Injury
    Date Received
    September 1, 2023
    Date of Event
    October 22, 2024
    Report Date
    October 22, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K014215
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: E2402 USED FOR "TUMOR INGROWTH". B3: AS NO DATE OF EVENT HAS BEEN REPORTED, 17 MONTHS AFTER THE DATE OF PUBLICATION HAS BEEN CHOSEN AS DATE OF EVENT AS THE INCIDENT REPORTED OCCURRED 13 MONTHS AFTER THE PLACEMENT OF THE SECOND DEVICE (WHICH OCCURRED 4 MONTHS AFTER THE INITIAL INTERVENTION) 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: UPDATED FOR FINAL CODING: A27 USED FOR "TUMOR INGROWTH". D12 USED FOR "THE GORE® VIABIL® BILIARY 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: "COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® VIABIL® BILIARY ENDOPROSTHESIS MAY INCLUDE COMPLICATIONS ASSOCIATED WITH OTHER BILIARY ENDOPROSTHESES. THESE COMPLICATIONS, WHICH MAY OR MAY NOT REQUIRED INTERVENTION, INCLUDE BUT ARE NOT LIMITED TO: ENDOPROSTHESIS DUE TO BIOFILM/SLUDGE FORMATION, EXTRINSIC COMPRESSION OR TUMOR OVERGROWTH AT THE ENDOPROSTHESIS ENDS". 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. B3: THE SPECIFIC DATE OF EVENT CAN¿T BE DETERMINED, THEREFORE THE DATE WHEN THE ARTICLE WAS PUBLISHED HAS BEEN CHOSEN.

    Additional Manufacturer Narrative · 0

    E1: UPDATES HAVE BEEN MADE TO THE DETAILS OF THE INITIAL COMPLAINANT AS THOSE SUBMITTED WERE INCORRECT. 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

    D17 - APPROPRIATE TERM/CODE NOT AVAILABLE IS BEING USED FOR "WITHDRAWN COMPLAINT". THIS MEDWATCH REPORT IS BEING WITHDRAWN, AND THE ALLEGED PRODUCT COMPLAINT HAS BEEN FOUND TO BE NOT REPORTABLE. THE INVESTIGATION HAS BEEN COMPLETED. BASED UPON THE TOTALITY OF THE INFORMATION RECEIVED OVER THE COURSE OF THE INVESTIGATION THE FOLLOWING CONCLUSIONS HAVE BEEN REACHED. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IN THE ABSENCE OF ADDITIONAL INFORMATION OR MEDICAL RECORDS FROM THE COMPLAINANT, THIS EVENT FILE WILL BE CLOSED WITH THE INFORMATION PROVIDED. THE INFORMATION FOR THIS CASE IS INCLUDED WITH MANUFACTURER REPORT NUMBER: 3003910212-2023-01493. UPON FURTHER REVIEW OF THE EVENT, IT WAS DETERMINED THAT THIS EVENT IS NOT REPORTABLE. THIS REPORT WILL BE RETRACTED.

    Description of Event or Problem · 0

    THE FOLLOWING CASE REPORT WAS RECEIVED: "LATE MIGRATION OF TWO COVERED BILIARY STENTS THROUGH A SPONTANEOUS BILIOENTERIC FISTULA IN A PATIENT WITH MALIGNANT BILIARY OBSTRUCTION", PUBLISHED BY MILTIADIS E KROKIDIS ET AL. ONLINE JUNE 23, 2007. ARTICLE CITATION: KROKIDIS, M. E., HATZIDAKIS, A. A., MANOUSAKI, E. G., & GOURTSOYIANNIS, N. C. (2008). LATE MIGRATION OF TWO COVERED BILIARY STENTS THROUGH A SPONTANEOUS BILIOENTERIC FISTULA IN A PATIENT WITH MALIGNANT BILIARY OBSTRUCTION. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 31(1), 222¿225. HTTPS://DOI.ORG/10.1007/S00270-006-0095-7. WITHIN THE CASE REPORT IT WAS STATED THAT THE PATIENT PRESENTED WITH A HISTORY OF CHOLECYSTECTOMY AND RECURRENT PANCREATITIS WAS ADMITTED TO HOSPITAL WITH JAUNDICE. REPORTEDLY ULTRASOUND SHOWED DILATATION OF THE BILIARY TREE, THE COMMON BILE DUCT (CBD), AND THE PANCREATIC DUCT. COMPUTED TOMOGRAPHY (CT) AND MAGNETIC RESONANCE CHOLANGIO-PANCREATOGRAPHY (MRCP) IDENTIFIED AN INOPERABLE MASS LOCATED AT THE UNCINATE PROCESS OF THE PANCREAS. IT WAS REPORTED THAT AFTER UNSUCCESSFUL ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP), THE PATIENT UNDERWENT A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) REVEALING A DISTAL CBD OBSTRUCTION. SUCCESSFUL PERCUTANEOUS DRAINAGE WAS SUBSEQUENTLY PERFORMED WITH THE PLACEMENT OF AN 8 FR FLEXIMA BILIARY CATHETER (BOSTON SCIENTIFIC, WATERTOWN, MA, USA). METALLIC STENTING FOLLOWED 8 DAYS LATER AND A GORE® VIABIL® BILIARY ENDOPROSTHESIS WITH PROXIMAL SIDE HOLES WAS SUCCESSFULLY IMPLANTED IN THE LOWER CBD. THE PATIENT WAS READMITTED WITH RECURRENCE OF JAUNDICE 4 MONTHS LATER AND THE NEW PTC SHOWED TUMOR IN- AND OVERGROWTH CAUSING ALMOST COMPLETE OBSTRUCTION OF THE PREVIOUSLY IMPLANTED STENT LUMEN. A SECOND STENT OF THE SAME SIZE AND TYPE WAS IMPLANTED IN THE MIDDLE PART OF THE CBD. DURING FOLLOW-UP, THERE WERE NO CLINICAL SIGNS OF JAUNDICE AND BLOOD TESTS WERE NORMAL. THE CT SCAN PERFORMED 9 MONTHS AFTER INSERTION OF THE SECOND STENT DOCUMENTED THE PRESENCE OF THE IMPLANTED ENDOPROSTHESES (MPDCASE-00015407). IT WAS REPORTED THAT THE PATIENT PRESENTED AGAIN, 13 MONTHS AFTER PLACEMENT OF THE SECOND STENT, WITH A COMPLAINT OF FATIGUE, WEAKNESS, AND ABDOMINAL PAIN. CLINICAL EXAMINATION AND BLOOD TESTS SUGGESTED STENT OCCLUSION. REPORTEDLY ULTRASOUND REVEALED DILATATION OF THE CBD WITH PROBABLE PRESENCE OF BILIARY STONES PROXIMAL TO THE OCCLUSION, WITHOUT A CLEAR EVIDENCE OF THE STENTS POSITION. PTC SHOWED A DILATED BILIARY TREE DUE TO AN OBSTRUCTION IN THE MIDDLE CBD. INTERESTINGLY, IT ALSO REVEALED THE PRESENCE OF A CHOLEDOCHO-DUODENAL COMMUNICATION THAT HAD NOT EXISTED IN THE FORMER PTCS AND THE ABSENCE OF THE TWO PREVIOUSLY IMPLANTED STENTS. THE CBD HAD SHORTENED, COMPARED WITH ITS LENGTH IN FORMER PTCS. PART OF THE TUMOR WAS ASSUMED TO HAVE DETACHED AND FORMED THIS CHOLEDOCHO-DUODENAL FISTULA, THEN THE NEOPLASTIC PART MIGRATED THROUGH THE FISTULA TOGETHER WITH THE TWO PREVIOUSLY IMPLANTED COVERED STENTS THAT WERE WELL ANCHORED IN THE TISSUE DUE TO TUMOR INGROWTH. IT WAS STATED THAT A THIRD NON-GORE STENT (BOSTON SCIENTIFIC) WAS POSITIONED THROUGH THIS PATHOLOGIC TRACT IN ORDER TO PRESERVE BILIOENTERIC COMMUNICATION. THE CT SCAN THAT FOLLOWED ALSO FAILED TO IDENTIFY THE MIGRATED STENTS ANYWHERE ALONG THE WHOLE GASTROINTESTINAL TRACT. THE BLOOD BILIRUBIN LEVELS WERE NORMALIZED 4 DAYS LATER AND THE PATIENT UNDERWENT A SURGICAL GASTROENTERIC ANASTOMOSIS IN THE FOLLOWING DAYS. THE CORRESPONDING AUTHOR HAS BEEN ASKED FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190474 GORE® VIABIL® BILIARY ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC FGE W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention