BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TIGRIS® VASCULAR STENT

    MDR report key: 5930272 · Received September 6, 2016

    Report

    Report Number
    2017233-2016-00732
    Event Type
    Injury
    Date Received
    September 6, 2016
    Date of Event
    June 4, 2016
    Report Date
    September 26, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: NIP / STENT, SUPERFICIAL FEMORAL ARTERY CONCOMITANT MEDICAL PRODUCTS: BOSTON SCIENTIFIC V18 GUIDEWIRE, MEDTRONIC PACIFIC PLUS 018 PTA BALLOON, LUTONIX 035 PTA BALLOON, 5MM X 100MM GORE TIGRIS VASCULAR STENT. THE PMA: P160004. (B)(4). A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE IMAGING EVALUATION STATED THAT THE AVAILABLE JPEG IMAGES WERE RECEIVED VIA EMAIL WITH NO INHERENT PATIENT IDENTIFIERS. UNABLE TO CHANGE WINDOW/LEVELING OR MAGNIFICATION OF AVAILABLE IMAGES. IN THE ANGIOGRAPHIC IMAGE PRIOR TO IMPLANT THERE APPEARS TO BE A LESION MID SFA. THERE ALSO APPEARS TO BE MULTIPLE SURGICAL CLIPS AT ABOUT THE LEVEL OF THE LESION. TWO DEVICES APPEAR TO HAVE BEEN SUCCESSFULLY IMPLANTED. POST IMPLANTATION THERE APPEARS TO BE A SIGNIFICANT GAP IN THE WIRE PATTERN OF DEVICE #1 (PROXIMAL DEVICE). THERE APPEARS TO BE A DISLOCATION OF WIRE PATTERN AT ABOUT THE MID PORTION OF DEVICE #1. UNABLE TO IDENTIFY WIRE FRACTURE WITH AVAILABLE IMAGES. THE DEVICE REMAINED IMPLANTED; CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A THROMBOENDARTERECTOMY WAS PERFORMED ON THE PATIENT IN THE SUPERFICIAL FEMORAL ARTERY ALONG WITH A VEIN BYPASS TO THE ABOVE-THE-KNEE POPLITEAL ARTERY. ON (B)(6) 2015, THE PATIENT PRESENTED WITH STENOSIS IN THE POPLITEAL ARTERY. PERCUTANEOUS BALLOON ANGIOPLASTY WAS PERFORMED WITH A 5MM BALLOON AND TWO GORE TIGRIS VASCULAR STENT WERE IMPLANTED. THE 5MM X 100MM TIGRIS DEVICE WAS INSERTED DISTALLY AND THE 5MM X 60MM WAS INSERTED PROXIMALLY OVER A BOSTON SCIENTIFIC V18 GUIDEWIRE. ON (B)(6) 2016, THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS. PERCUTANEOUS BALLOON ANGIOPLASTY WAS PERFORMED WITH A MEDTRONIC PACIFIC PLUS 018 DISTALLY AND LUTONIX 035 PROXIMALLY. ON (B)(6) 2016, THE PATIENT PRESENTED WITH RE-STENOSIS. IT WAS REPORTED TO GORE THAT A STENT FRACTURE WAS OBSERVED. A ZILVER PT STENT WAS IMPLANTED TO BRIDGE THE GAP IN THE REPORTEDLY FRACTURED STENT. IT WAS STATED THAT NO PROBLEMS WERE OBSERVED AT THE MAY 3 INTERVENTIONS BUT RETROSPECTIVELY THE FRACTURE IN THE UPPER STENT MOST LIKELY OCCURRED AT THAT INTERVENTION. THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582079 GORE TIGRIS® VASCULAR STENT NIP W.L. GORE & ASSOCIATES 13926853

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention