BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS - 3

    MDR report key: 9078736 · Received September 17, 2019

    Report

    Report Number
    2017233-2019-00870
    Event Type
    Injury
    Date Received
    September 17, 2019
    Date of Event
    June 17, 2015
    Report Date
    October 25, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. CONCLUSION CODE 1: UPDATED.

    Additional Manufacturer Narrative · 0

    REF: MFR REPORT # 2017233-2019-00871 FOR GORE® PROPATEN® VASCULAR GRAFT EVENT.

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: KROL, EMILIA, BRANDT, COLIN T., BLAKESLEE-CARTER, JULIET, AHANCHI, SADIE S., DEXTER, DAVID J., KARAKLA, DANIEL, AND PANNETON, JEAN M. 2019 VASCULAR INTERVENTIONS IN HEAD AND NECK CANCER PATIENTS AS A MARKER OF POOR SURVIVAL. JOURNAL OF VASCULAR SURGERY 69:181-189. THIS REPORT ADDRESSES POTENTIAL, BUT UNCONFIRMED, INSTANCES OF LOSS OF PATENCY WITH VIABAHN. THE PROPATEN GRAFT IS BEING REPORTED SEPARATELY.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: IN AN ABSTRACT TITLED "VASCULAR INTERVENTIONS IN HEAD AND NECK CANCER PATIENTS AS A MARKER OF POOR SURVIVAL", IT STATES A RETROSPECTIVE REVIEW OF CANCER PATIENTS TREATED BY HEAD AND NECK SURGERY AND VASCULAR SURGERY BETWEEN 2007 AND 2015 WAS CONDUCTED. TWENTY-TWO PATIENTS HAD STENTS PLACED DURING INDEX PROCEDURES. GORE® VIABAHN® ENDOPROSTHESES WERE UTILIZED IN EIGHT PATIENTS. ADDITIONALLY, EIGHT BYPASS PROCEDURES WERE PERFORMED, SEVEN HAD VEIN GRAFTS. ONE BYPASS PATIENT HAD A GORE® PROPATEN® VASCULAR GRAFT, FOR RECURRENT CAROTID STENOSIS FROM RADIATION ARTERITIS. THE PRIMARY PATENCY RATES FOR BOTH BYPASS AND STENTS WERE ANALYZED. THE MEAN PATENCY RATE FOR PATENCY WITH BYPASS WAS 16.6 MONTHS (RANGE, 1 DAY TO 23 MONTHS) COMPARED WITH 29.8 MONTHS (RANGE 3 DAYS TO 55 MONTHS) FOR PATIENTS TREATED WITH STENTS. PRIMARY PATENCY AT 1 YEAR WAS 71% AND 66% FOR BYPASS AND STENT PATIENTS RESPECTIVELY. THERE WAS NO DIFFERENCE BETWEEN THE PRIMARY PATENCY FOR THE TWO GROUPS (P=.604).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871306 GORE VIABAHN ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| O