BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 10451995 · Received August 25, 2020

    Report

    Report Number
    2017233-2020-01165
    Event Type
    Injury
    Date Received
    August 25, 2020
    Date of Event
    January 6, 2020
    Report Date
    October 23, 2020
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INSTRUCTIONS FOR USE FOR GORE® VIABAHN® ENDOPROSTHESIS (IFU): INTENDED USE / INDICATIONS: THE GORE® VIABAHN® ENDOPROSTHESIS IS A FLEXIBLE, SELF-EXPANDING ENDOLUMINAL PROSTHESIS FOR ENDOVASCULAR GRAFTING OF PERIPHERAL ARTERIES. 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: IN THE ARTICLE, O'CONNOR KP, BOHNSTEDT BN. VIABAHN STENT EXTRUSION INTO THE AIRWAY IN ASSOCIATION WITH NASOPHARYNGEAL SQUAMOUS CELL CARCINOMA. INTERDISCIPLINARY NEUROSURGERY 2019;18. ARTICLE 100464. VIABAHN WAS PLACED IN THE CAROTID ARTERY OF A PATIENT WITH NASOPHARYGEAL SQUAMOUS CELL CARCINOMA TO TREAT "CAROTID BLOWOUT SYNDROME". SIX MONTHS LATER, THE STENT WAS EXTRUDED INTO THE AIRWAY AND THE PATIENT COUGHED UP THE STENT. THE AUTHORS CONCLUDE: "OUR PATIENT HAD STENT EXTRUSION INTO THE AIRWAY APPROXIMATELY SIX MONTHS AFTER PLACEMENT. THE PATIENT REPORTED TO THE CLINIC ONE WEEK AFTER EXTRUSION WITHOUT BLEEDING OR SYMPTOMATOLOGY. CT NECK ANGIOGRAPHY DEMONSTRATED THAT THE VESSEL THROMBOSED FROM THE COMMON CAROTID AT THE LEVEL JUST OFF THE AORTIC ARCH TO THE INTERNAL CAROTID AT THE LEVEL OF THE CAVERNOUS SINUS. THE PATIENT ALSO HAD SUFFICIENT COLLATERAL FLOW FROM THE CONTRALATERAL SIDE WHICH ALLOWED AVOIDANCE OF NEUROLOGICAL SYMPTOMS SECONDARY TO BRAIN ISCHEMIA. WE BELIEVE THIS TO BE A UNIQUE SITUATION FOLLOWING VESSEL PROTECTION. THE PATIENT EXPERIENCED VESSEL OCCLUSION WITH STENT EXTRUSION."

    Additional Manufacturer Narrative · 1

    INSTRUCTIONS FOR USE FOR GORE® VIABAHN® ENDOPROSTHESIS (IFU): INTENDED USE / INDICATIONS: THE GORE® VIABAHN® ENDOPROSTHESIS IS A FLEXIBLE, SELF-EXPANDING ENDOLUMINAL PROSTHESIS FOR ENDOVASCULAR GRAFTING OF PERIPHERAL ARTERIES.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS REVIEWED: IN THE ARTICLE, O'CONNOR KP, BOHNSTEDT BN. VIABAHN STENT EXTRUSION INTO THE AIRWAY IN ASSOCIATION WITH NASOPHARYNGEAL SQUAMOUS CELL CARCINOMA. INTERDISCIPLINARY NEUROSURGERY 2019;18. ARTICLE 100464. VIABAHN WAS PLACED IN THE CAROTID ARTERY OF A PATIENT WITH NASOPHARYGEAL SQUAMOUS CELL CARCINOMA TO TREAT "CAROTID BLOWOUT SYNDROME". SIX MONTHS LATER, THE STENT WAS EXTRUDED INTO THE AIRWAY AND THE PATIENT COUGHED UP THE STENT. THE AUTHORS CONCLUDE: "OUR PATIENT HAD STENT EXTRUSION INTO THE AIRWAY APPROXIMATELY SIX MONTHS AFTER PLACEMENT. THE PATIENT REPORTED TO THE CLINIC ONE WEEK AFTER EXTRUSION WITHOUT BLEEDING OR SYMPTOMATOLOGY. CT NECK ANGIOGRAPHY DEMONSTRATED THAT THE VESSEL THROMBOSED FROM THE COMMON CAROTID AT THE LEVEL JUST OFF THE AORTIC ARCH TO THE INTERNAL CAROTID AT THE LEVEL OF THE CAVERNOUS SINUS. THE PATIENT ALSO HAD SUFFICIENT COLLATERAL FLOW FROM THE CONTRALATERAL SIDE WHICH ALLOWED AVOIDANCE OF NEUROLOGICAL SYMPTOMS SECONDARY TO BRAIN ISCHEMIA. WE BELIEVE THIS TO BE A UNIQUE SITUATION FOLLOWING VESSEL PROTECTION. THE PATIENT EXPERIENCED VESSEL OCCLUSION WITH STENT EXTRUSION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914840 GORE VIABAHN ENDOPROSTHESIS STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 DA Hospitalization