BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENFIELD¿

    MDR report key: 6856152 · Received September 11, 2017

    Report

    Report Number
    2134265-2017-09002
    Event Type
    Injury
    Date Received
    September 11, 2017
    Report Date
    August 22, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DTK
    PMA / PMN Number
    K901659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH # 5071364 THAT THE PATIENT EXPERIENCED A PERFORATION. IN (B)(6) 1992 THE PATIENT UNDERWENT AN INFERIOR VENA CAVA FILTER PROCEDURE WHERE A GREENFIELD¿ FILTER WAS IMPLANTED. HOWEVER, POST PROCEDURE THE PATIENT HAD EXPERIENCED SHARP, STABBING PAIN IN THE LOWER LEFT QUADRANT OF THEIR ABDOMEN. COMPUTED TOMOGRAPHY (CT) SCANS WERE PERFORMED AND IT WAS DETERMINED THAT THE PRONGS OF THE FILTER HAD MIGRATED INTO THE STOMACH WALL AND WERE PUNCTURING THE SMALL INTESTINE, CLOSE TO THE AORTA. IN 2010 THE IVC FILTER WAS SUCCESSFULLY REMOVED. SINCE THEN THE PATIENT HAS SUFFERED FROM CHRONIC STOMACH ISSUES AND A RECENT COLONOSCOPY REVEALED THAT THE IVC FILTER PERFORATION HAD CREATED ADHESIONS IN THEIR INTESTINAL TRACK CAUSING PRE-CANCEROUS POLYPS THAT NOW REQUIRE REGULAR MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635157 GREENFIELD¿ FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BOSTON SCIENTIFIC - MAPLE GROVE M001503010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention