BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 8251995 · Received January 16, 2019

    Report

    Report Number
    3002808486-2019-00072
    Event Type
    Injury
    Date Received
    January 16, 2019
    Report Date
    February 18, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). D4) CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK IVC FILTER E3) OCCUPATION: NON-HEALTHCARE PROFESSIONAL G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: IT HAS NOT BEEN POSSIBLE TO INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING ¿UNABLE TO RETRIEVE, EMBEDDED, FILTER THROMBUS". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. A FILTER THAT IS EMBEDDED IN THE WALL OF THE IVC MAY BE DIFFICULT TO RETRIEVE. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. IVC FILTER THROMBUS, OR CLOT IN IVC FILTER, IS AN OUTCOME WHERE THE FILTER HAS EITHER ENTRAPPED A CLOT THAT HAS EMBOLIZED FROM AN UPSTREAM SOURCE, SUCH AS A DEEP VEIN THROMBUS, OR WHERE A CLOT HAS FORMED ON OR WITHIN THE FILTER. FILTER THROMBUS CAN EITHER RESOLVE THROUGH THE PROCESS OF THROMBOLYSIS, REMAIN STATIONARY WITHOUT SUBSEQUENT SEQUELAE, OR ALTERNATIVELY PROVIDE A NIDUS FOR ADDITIONAL CLOT FORMATION. THE PRESENCE OF A FILTER THROMBUS COULD PRECLUDE THE REMOVAL OF THE FILTER DURING A RETRIEVAL PROCESS DUE TO POTENTIAL DISLODGEMENT OF THE THROMBUS WHICH COULD CAUSE A DOWNSTREAM OCCLUSIVE EVENT, E.G. PULMONARY EMBOLISM. IVC FILTER THROMBUS IS DOCUMENTED BY ULTRASOUND (US), CT, MR IMAGING OR VENOGRAPHY. 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 MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO CATEGORIZATION FORM: [PT] ALLEGES: "FAILED RETRIEVAL ATTEMPT DUE TO EMBEDDED LEG", "FILTER LEGS EMBEDDED IN LEFT LATERAL ASPECT OF THE IVC WALL", "FILTER CLOT IDENTIFIED BY IMAGERY FOLLOWING FAILED RETRIEVAL ATTEMPT" PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46609 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening