BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 10099845 · Received May 29, 2020

    Report

    Report Number
    3002808486-2020-00580
    Event Type
    Injury
    Date Received
    May 29, 2020
    Report Date
    August 11, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    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 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED THAT CONFIRMS THE DEVICE WAS MANUFACTURED BY COOK INC.

    Additional Manufacturer Narrative · 1

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK GUNTHER TULIP FILTER. OCCUPATION: NON-HEALTHCARE PROFESSIONAL. PMA/510(K) K172557. SUMMARY OF INVESTIGATIONAL FINDINGS: THE REPORTED ALLEGATIONS HAVE BEEN FURTHER 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. 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. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "ON OR ABOUT (B)(6) 2010, [PT] WAS IMPLANTED WITH THE COOK FILTER. ON OR ABOUT (B)(6) 2019, [PT] UNDERWENT A COMPUTED TOMOGRAPHY (CT) SCAN OF HER ABDOMEN AND PELVIS. THE CT SCAN REVEALED THAT THE COOK FILTER STRUTS HAD MOVED SINCE THE FILTER WAS PLACED, WITH SEVERAL STRUTS PERFORATING [PT]'S INFERIOR VENA CAVA". PATIENT OUTCOME: ALLEGED THAT "[PT] IS AT RISK FOR FUTURE COOK FILTER FRACTURES, MIGRATIONS, PERFORATIONS AND TILTING. SHE FACE'S NUMEROUS HEALTH RISKS, INCLUDING THE RISK OF DEATH. FOR THE REST OF [PT]'S LIFE, SHE' WILL REQUIRE ON-GOING MEDICAL MONITORING AND USE OF ANTI-COAGULANTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563892 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening