BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 8154245 · Received December 12, 2018

    Report

    Report Number
    3002808486-2018-01443
    Event Type
    Injury
    Date Received
    December 12, 2018
    Report Date
    June 27, 2019
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. 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. FILTER OR FILTER FRAGMENT MIGRATION AND (OR) EMBOLIZATION (E.G., MOVEMENT TO THE HEART OR LUNGS) HAS BEEN REPORTED. FILTER OR FILTER FRAGMENT MOVEMENT HAS OCCURRED IN BOTH THE CRANIAL AND CAUDAL DIRECTION AND MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. POTENTIAL CAUSES MAY INCLUDE FILTER PLACEMENT IN IVCS WITH DIAMETERS SMALLER OR LARGER THAN THOSE SPECIFIED IN THESE INSTRUCTIONS FOR USE; IMPROPER DEPLOYMENT; DEPLOYMENT INTO THROMBUS; DISLODGEMENT DUE TO LARGE THROMBUS BURDENS; 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: FILTER MIGRATION, TRAUMA TO ADJACENT STRUCTURES. UNKNOWN IF THE REPORTED HEMATURIA IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS TIME. 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. EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). NAME AND ADDRESS FOR IMPORTER SITE:COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 . REGISTRATION NO.: (B)(4).

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). D4) CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK CELECT 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. 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.

    Additional Manufacturer Narrative · 0

    PATIENT CODE: HEMATURIA (2558), NOT LISTED IN IFU, VESSELS, PERFORATION OF (2135), LISTED IN IFU; ORGAN(S), PERFORATION OF (1987), NOT LISTED IN IFU; DEVICE CODE: MIGRATION (4003), LISTED IN IFU APPROPRIATE TERM/CODE NOT AVAILABLE (3191) [DEVICE PERFORATION], NOT LISTED IN IFU; THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME 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. EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI), 400 DANIELS WAY, BLOOMINGTON, IN 47404, REGISTRATION NO.: 3005580113.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2010 ((B)(4)) AND A COOK CELECT FILTER ON (B)(6) 2014 ((B)(4))". PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Description of Event or Problem · 0

    PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2010 VIA THE RIGHT FEMORAL VEIN DUE TO HISTORY OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE). PATIENT ALLEGES MIGRATION, VENA CAVA PERFORATION AND ORGAN PERFORATION. PATIENT FURTHER ALLEGES TO HAVE EXPERIENCED, "IVC PENETRATED MY RIGHT KIDNEY AND I KEPT PASSING BLOOD." THE FILTER WAS RETRIEVED ON (B)(6) 2013, DUE TO FILTER PENETRATION INTO RIGHT RENAL CAUSING HEMATURIA. PER OPERATIVE NOTES (FILTER RETRIEVAL), DATED (B)(6) 2013, "AT THE LEVEL OF THE FILTER, THE INFERIOR VENA CAVA APPEARS RELATIVELY NARROWED. THERE IS CLEARLY EVIDENCE OF THE PRONG ON THE RIGHT SIDE OF THE VENA CAVA FILTER TO BE DIRECTED LATERALLY IN THE DIRECTION OF THE RIGHT RENAL PELVIS. THIS PRONG IS UNDOUBTEDLY THE CULPRIT IN PENETRATING THE RENAL PELVIS AND BECAUSE OF THE GROSS RECURRENT HEMATURIA. SUCCESSFUL RETRIEVAL OF COOK CELECT INFERIOR VENA CAVA (3 YEARS SUBSEQUENT TO PLACEMENT) VIA RIGHT INTERNAL JUGULAR ACCESS." THIS IS 1 OF 2 REPORTS, THE RELATED EVENT IS MFR# 3002808486-2018-01444.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994350 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R