BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIANTURCO-ROEHM BIRD'S NEST JUGULAR VENA CAVA FILTER

    MDR report key: 2090063 · Received May 5, 2011

    Report

    Report Number
    1820334-2011-00221
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 5, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DTK
    PMA / PMN Number
    P850049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION - UNK AS LOT IS UNK. PERFORATION IS LABELED IN THE IFU. QUALITY CONTROL VERIFIES GAUGE, LENGTH, POSITION, AND BEVEL TYPE OF THE BARBS. THE PRODUCT IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) WHICH LISTS PERFORATION OF VENA CAVE WALL AS A POTENTIAL ADVERSE EVENT. ADDITIONALLY, THE IFU STATES, "IF FILTER MIGRATION OCCURS, TRANSCATHETER RETRIEVAL OF THE FILTER IS NOT RECOMMENDED." ONLY IMAGES WERE RETURNED. REVIEW OF THE IMAGES SUGGEST THAT THE DEVICE IS LIKELY A BIRD'S NEST FILTER DUE TO THE VISIBILITY OF THE HOOK WIRE STRUTS. IT APPEARS THAT THE STRUTS HAVE PERFORATED THE VENA CAVA. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL. A QUALITY ENGINEERING RISK ANALYSIS (QERA) WAS CREATED IN RESPONSE TO THIS CASE. NO FURTHER MITIGATING ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 1991, THE PT UNDERWENT FILTER PLACEMENT AT A HOSP IN (B)(6) (HOSP #1). IN 2011, THE PT MOVED TO A DISTANT PREFECTURE. CURRENTLY, CT SCAN WAS TAKEN AT ANOTHER HOSP (HOSP #2) AND IT SHOWED THE FILTER SEEMED TO PERFORATE THE VESSEL AND IT MAY HAVE REACHED ARTERY. SHE WAS SENT TO ANOTHER HOSP (HOSP #3). THE DOCTOR THERE THOUGHT THE FILTER LOOKED LIKE THE BIRD'S NEST, SO CALLED A SALES REP AND SHOWED IMAGES. THE SALES REP ALSO THOUGHT IT LOOKED LIKE THE BIRD'S NEST, BUT IS STILL IS NOT SURE IT IS. HOWEVER, HE DECIDED TO REPORT AND CHECK SIMILAR EVENTS HAVE OCCURRED FOR THE DOCTOR. THE PT'S CONDITION IS UNK AS NOT PROVIDED BY REPORTER. INFO PROVIDED ON (B)(6) 2011: THE PT WAS NOT EXPERIENCING ANY SYMPTOMS RELATED TO THE FILTER PLACEMENT. THE FILTER MATTER WAS JUST DISCOVERED WHEN THE CT SCAN WAS TAKEN FOR A DIFFERENT MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIANTURCO-ROEHM BIRD'S NEST JUGULAR VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other