BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIANTURCO-ROEHM BIRD'S NEST JUGULAR VENA CAVA FILTER

    MDR report key: 5527125 · Received March 25, 2016

    Report

    Report Number
    1820334-2016-00185
    Event Type
    Injury
    Date Received
    March 25, 2016
    Report Date
    March 4, 2016
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). K073528. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION RESULTS - THE COMPLAINT DEVICE WAS NOT RETURNED FOR INVESTIGATION AS IT IS STILL IMPLANTED IN THE PATIENT. A FULL REVIEW OF COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROLS, AND PRODUCT TRENDS WAS CONDUCTED. THE PRODUCT LOT NUMBER WAS NOT REPORTED, SO A SEARCH OF PRODUCTION INFORMATION AND NONCONFORMANCE DATA CANNOT BE CONDUCTED. WITHOUT ADDITIONAL IMAGING IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS INCIDENT. PRODUCT IS INSPECTED PER QUALITY CONTROL PROCEDURES TO VERIFY THAT THE DEVICE IS MANUFACTURED TO SPECIFICATIONS. THE PRODUCT IS SHIPPED WITH AN INSTRUCTIONS FOR USE (IFU) WHICH LISTS THE ANATOMICAL REQUIREMENTS, WARNINGS AND PRECAUTIONS, AND CORRECT DEPLOYMENT PROCEDURE. THE EXACT IFU IS DEPENDENT ON PRODUCT SIZE AND PLACEMENT APPROACH. WITHOUT THE EXACT DEVICE, WE CANNOT DETERMINE THE EXACT IFU. HOWEVER, IN EACH IFU, PERFORATION OF VENA CAVA WALL IS LISTED AS A POTENTIAL ADVERSE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURING TO SPECIFICATION. COOK (B)(4) WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    A MALE PATIENT HAD A BIRDS NEST FILTER INSITU (UNKNOWN FOR HOW LONG OR WHEN IT WAS IMPLANTED). UNDER CT, IT WAS NOTED A PART OF THE FILTER APPEARED TO BE PENETRATING THE CAVA WALL. NO ACTION TAKEN IN RELATION TO THIS HAS BEEN REPORTED. ACCORDING TO THE INITIAL REPORTER, THE DEVICE REMAINS INSIDE THE PATIENT AND WILL NOT BE REMOVED. NO ADDITIONAL PROCEDURES OR ADVERSE EFFECTS REPORTED.

    Description of Event or Problem · 1

    A MALE PATIENT HAD A BIRDS NEST FILTER INSITU (UNKNOWN FOR HOW LONG OR WHEN IT WAS IMPLANTED). UNDER CT, IT WAS NOTED A PART OF THE FILTER APPEARED TO BE PENETRATING THE CAVA WALL. NO ACTION TAKEN IN RELATION TO THIS HAS BEEN REPORTED. ACCORDING TO THE INITIAL REPORTER, THE DEVICE REMAINS INSIDE THE PATIENT AND WILL NOT BE REMOVED. NO ADDITIONAL PROCEDURES OR ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181618 GIANTURCO-ROEHM BIRD'S NEST JUGULAR VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other