BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TIGRIS® VASCULAR STENT

    MDR report key: 6018990 · Received October 11, 2016

    Report

    Report Number
    2017233-2016-00790
    Event Type
    Injury
    Date Received
    October 11, 2016
    Date of Event
    September 28, 2016
    Report Date
    September 30, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: NIP / STENT, SUPERFICIAL FEMORAL ARTERY. CONCOMITANT PRODUCT: (B)(6) 2016 6MM GORE® TIGRIS® VASCULAR STENT PHB061001 LOT 14452703. PMA: P160004. UDI: (B)(4); LOT: 14507173. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE REMAINED IMPLANTED; CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    ON (B)(6) 2016, TWO GORE® TIGRIS® VASCULAR STENTS WERE IMPLANTED FOR THE TREATMENT OF A LONG SUPERFICIAL FEMORAL ARTERY CALCIFICATION. DISTALLY A 5MM TIGRIS® DEVICE WAS IMPLANTED AND PROXIMALLY A 6MM DEVICE. IT WAS REPORTED TO GORE THAT ON (B)(6) 2016, THERE WAS EVIDENCE OF DISTAL STENOSIS AT THE 3 WEEK FOLLOW-UP. IT WAS STATED THAT RE-ANGIOPLASTY WAS NOT POSSIBLE AND THE PATIENT'S ARTERIES WERE NOT SUITABLE FOR A DISTAL BYPASS. THEREFORE, A FOREFOOT AMPUTATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669829 GORE TIGRIS® VASCULAR STENT NIP W.L. GORE & ASSOCIATES 14507173

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Disability