BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 15230979 · Received August 16, 2022

    Report

    Report Number
    2017233-2022-03214
    Event Type
    Injury
    Date Received
    August 16, 2022
    Date of Event
    May 2, 2021
    Report Date
    August 16, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE SERIAL/LOT NUMBER REMAINS UNKNOWN. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE AND/OR PRODUCTION DETAILS CANNOT BE DETERMINED, AND THE INFORMATION PROVIDED TO GORE CANNOT BE CONNECTED TO A SPECIFIC DEVICE. THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: FIGURE 1 SHOWS: IMAGES A AND B APPEAR TO SHOW A CAROTID INTERNAL JUGULAR FISTULA WITH A PSEUDOANEURYSM. IMAGES C AND D SHOW A STENT GRAFT(S) IN THE LEFT COMMON CAROTID ARTERY/CAROTID ARTERY, WITH RESOLUTION OF THE FISTULA AND PSEUDOANEURYSM. IMAGE E SHOWS STENOSIS NEAR THE DISTAL END OF THE STENT GRAFT(S) IN THE LEFT COMMON CAROTID ARTERY. IMAGE F AND G ILLUSTRATE THE IMPLANTED STENT GRAFT(S) TO BE OCCLUDED WITH STENOSIS IN THE LEFT COMMON CAROTID ARTERY. FIGURE 2 SHOWS: FLOW IS RESTORED AFTER OPEN REPAIR WITH AN END TO END VASCULAR GRAFT. DEVICE PHOTOS AFTER REMOVAL WERE ALSO PROVIDED IN THE LITERATURE ARTICLE ILLUSTRATING RED THROMBUS WITHIN THE REMOVED STENT GRAFT. THE AVAILABLE INFORMATION REPORTED IN THE COMPLAINT, INCLUDING CLINICAL IMAGES WITHIN THE LITERATURE ARTICLE, DOES NOT REASONABLY SUGGEST A POTENTIAL MALFUNCTION HAS OCCURRED. CITATION: YUN-FENG HAN, TAO WANG, YUN-PENG LING AND HONG ZHAO. CAROTID ENDARTERECTOMY WITH STENT GRAFT REMOVAL AND END TO END BYPASS IN THE TREATMENT OF IN-STENT OCCLUSION AFTER ENDOVASCULAR THERAPY OF CAROTID GUNSHOT INJURY. ANNALS OF VASCULAR SURGERY, VOLUME 76, P591-596, 2021. CBAS® 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.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS RECEIVED THROUGH LITERATURE ¿CAROTID ENDARTERECTOMY WITH STENT GRAFT REMOVAL AND END TO END BYPASS IN THE TREATMENT OF IN-STENT OCCLUSION AFTER ENDOVASCULAR THERAPY OF CAROTID GUNSHOT INJURY¿ PUBLISHED BY ANNALS OF VASCULAR SURGERY, VOLUME 76, P591-596, 2021. THE PUBLICATION IS A CASE REPORT. THE AUTHORS DESCRIBE THE CASE OF A 30-YEAR-OLD MAN WITH CAROTID JUGULAR FISTULA AND PSEUDOANEURYSM AFTER GUNSHOT INJURY OF LEFT CAROTID ARTERY WHO HAD RECEIVED STENT GRAFT PLACEMENT (VIABAHN DEVICE). HOWEVER, TWO YEARS AFTER STENT GRAFT, THE STENOSIS OF PROXIMAL CAROTID ARTERY NEAR STENT WAS FOUND AND GRADUALLY AGGRAVATED. DURING THE FOLLOW-UP, TRANSIENT AMAUROSIS OF HIS LEFT EYE OCCURRED INTERMITTENTLY AND IN-STENT OCCLUSION AND SEVERE STENOSIS OF PROXIMAL CAROTID ARTERY WERE FOUND BY COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IN THE CENTER. CAROTID ENDARTERECTOMY (CEA) WITH STENT GRAFT REMOVAL AND END TO END BYPASS USING VASCULAR GRAFT (DIAMETER 6 MM, HEPARIN COVERED, INTEGRATED RING, GORE) WAS PERFORMED TO RECONSTRUCT THE BLOOD FLOW OF LEFT CAROTID ARTERY. AT 12 MONTHS AFTER THE OPERATION, CTA REVEALED THAT THE LUMEN OF CAROTID ARTERY AND VASCULAR GRAFT WERE UNOBSTRUCTED WITHOUT STENOSIS OR THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011810 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Required Intervention