BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 13031329 · Received December 17, 2021

    Report

    Report Number
    3002808486-2021-02046
    Event Type
    Injury
    Date Received
    December 17, 2021
    Report Date
    April 22, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC. WITH THE SUBMISSION OF THIS FOLLOW UP REPORT, WILLIAM COOK EUROPE INFORMS THAT THIS COMPLAINT HAS BEEN TRANSFERRED FROM WILLIAM COOK EUROPE TO COOK INC. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER OCCUPATION: NON-HEALTHCARE PROFESSIONAL INVESTIGATION: THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: VENA CAVA PERFORATION. THE REPORTED ALLEGATIONS HAVE BEEN INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. FILTER INTERACTS WITH IVC WALL, E.G. PENETRATION/PERFORATION/EMBEDMENT. THIS MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. POTENTIAL CAUSES MAY INCLUDE IMPROPER DEPLOYMENT; AND (OR) EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IN-SITU FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER). POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: TRAUMA TO ADJACENT STRUCTURES, VASCULAR TRAUMA, VENA CAVA PERFORATION, VENA CAVA PENETRATION. CATALOG NUMBER AND LOT NUMBER ARE UNKNOWN. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC. WITH THE SUBMISSION OF THIS FOLLOW UP REPORT, WILLIAM COOK EUROPE INFORMS THAT THIS COMPLAINT HAS BEEN TRANSFERRED FROM WILLIAM COOK EUROPE TO COOK INC.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION IS ALLEGED: THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2013. APPROXIMATELY SIX YEARS AND SIX MONTHS LATER, IT WAS NOTED THAT THE IVC FILTER PENETRATED THE VENA CAVA, SEVERAL STRUTS EXTENDED BEYOND THE IVC WALL. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928526 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening