BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 8747209 · Received July 1, 2019

    Report

    Report Number
    3002808486-2019-00840
    Event Type
    Injury
    Date Received
    July 1, 2019
    Report Date
    August 21, 2019
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E232614 WAS REPORTED AS THE LOT NUMBER FOR THE COMPLAINT DEVICE. DEVICE CODE(S): APPROPRIATE TERM/CODE NOT AVAILABLE (3191) WAS SELECTED FOR THE ALLEGED DEVICE PERFORATION. THE INVESTIGATION WAS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: VENA CAVA PERFORATION, POST-IMPLANT DVT (DEEP VEIN THROMBOSIS), POST-IMPLANT PAIN, ANXIETY/WORRY, MENTAL ANGUISH, AND STRESS. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. VENA CAVA WALL PENETRATION/PERFORATION HAS BEEN REPORTED AND 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. . UNKNOWN IF THE REPORTED POST-IMPLANT DVT, POST-IMPLANT PAIN, ANXIETY/WORRY, MENTAL ANGUISH, AND STRESS ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 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. 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.

    Description of Event or Problem · 0

    PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2009 VIA THE COMMON FEMORAL VEIN DUE TO PRIOR COMBO DVT (DEEP VEIN THROMBOSIS)/ PE (PULMONARY EMBOLISM) SADDLE PE W/ RV (RIGHT VENTRICLE) DILATION. PATIENT IS ALLEGING VENA CAVA PERFORATION, POST-IMPLANT DVTS, AND POST-IMPLANT PAIN. THE PATIENT IS FURTHER ALLEGING "I AM NOT CERTAIN WHICH SPECIFIC SYMPTOMS OR BODILY INJURIES I MAY HAVE SUFFERED AS A RESULT OF THE COOK INFERIOR VENA CAVA FILTER. I AM RELYING ON THE EXPERTS THAT WILL BE RETAINED BY MY LAWYER TO DETERMINE THIS INFORMATION. HOWEVER, THE IVC FILTER PERFORATED THE VENA CAVA WALL. I EXPERIENCED A DVT AND PAIN POST-IMPLANT. I ALSO EXPERIENCE ANXIETY, MENTAL ANGUISH AND STRESS ABOUT THE STATUS OF MY FILTER AND ANY RELATED INJURIES." AND "I CANNOT RECALL THE EXACT DATE I BEGAN TO WORRY AND HAVE ANXIETY ABOUT THE STATUS OF MY FILTER AND ANY RELATED INJURIES AND HAVE NOT TREATED WITH A PHYSICIAN FOR THESE CONDITIONS."

    Additional Manufacturer Narrative · 1

    MANUFACTURERS REF# (B)(4). CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK CELECT FILTER. OCCUPATION: NON-HEALTHCARE PROFESSIONAL. IT HAS NOT BEEN POSSIBLE TO INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVING WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "PT RECEIVED A COOK CELECT FILTER ON (B)(6) 2009". 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
    541007 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening