BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 10506400 · Received September 9, 2020

    Report

    Report Number
    3002808486-2020-00860
    Event Type
    Injury
    Date Received
    September 9, 2020
    Report Date
    June 18, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    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

    MANUFACTURER REF# (B)(4). 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: IT IS ALLEGED THAT "THE COOK FILTER WAS PLACED IN [PT]¿S BODY ON OR ABOUT (B)(6) 2010. [PT] DISCOVERED THAT THE COOK FILTER PERFORATED HER VENA CAVA NO EARLIER THAN (B)(6) 2019." PATIENT OUTCOME: IT IS ALLEGED THAT "[PT] WAS CAUSED TO UNDERGO MEDICAL TREATMENT AS A RESULT OF THE FAILURE OF THE COOK FILTER. [PT] HAS INCURRED SIGNIFICANT MEDICAL EXPENSES AND HAS ENDURED PHYSICAL PAIN AND SUFFERING, MENTAL ANGUISH, LOSS OF ENJOYMENT OF LIFE, AND OTHER LOSSES, SOME OF WHICH ARE PERMANENT IN NATURE. AS A RESULT OF THE FAILURE OF THE COOK FILTER, [PT] HAS BECOME IMPAIRED AND WILL REMAIN SO IN THE FUTURE. THE DEFECTIVE COOK FILTER REMAINS IN [PT]¿S BODY AFTER REMOVAL WAS NOT ATTEMPTED DUE TO THE LIFE-THREATENING RISK ASSOCIATED WITH THE PROCEDURE. [PT] IS REQUIRED TO ATTEND REGULAR PHYSICIANS' VISITS AND TO UNDERGO IMAGING STUDIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972091 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening