BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 6563892 · Received May 12, 2017

    Report

    Report Number
    1820334-2017-00980
    Event Type
    Malfunction
    Date Received
    May 12, 2017
    Report Date
    April 19, 2019
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330167
    PMA / PMN Number
    K043509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. PER QUALITY ENGINEERING REVIEW, THE ADDITIONAL INFORMATION PROVIDED FOR THIS COMPLAINT DOES NOT CHANGE THE PREVIOUS INVESTIGATION CONCLUSION. THEREFORE, NO NEW INVESTIGATION ACTIVITIES WILL BE CONDUCTED AT THIS TIME. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. 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. 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. UPDATE - CINC: PRODUCT SPECIFICATION SPEC_(B)(4) GIVES INSTRUCTIONS PERTAINING TO THIS DEVICE. THE SPECIFICATION STATES, "PRODUCT IS MANUFACTURED, INSPECTED AND PACKAGED BY WILLIAM COOK EUROPE A/S (B)(4) 14-AUG-2017. 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.

    Description of Event or Problem · 0

    PATIENT ALLEGES MIGRATION.

    Additional Manufacturer Narrative · 1

    WILLIAM COOK (B)(4) INITIALLY REPORTED EVENT UNDER MFR REPORT # 3002808486-2016-01375. NEW INFORMATION WAS RECEIVED IDENTIFYING THAT THE PRODUCT WAS A COOK INC. MANUFACTURED DEVICE. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING "DEVICE UNABLE TO BE RETRIEVED, ABDOMINAL PAIN, SHORTNESS OF BREATH, LEFT FOOT NUMBNESS, DEPRESSION". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. 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. UNKNOWN IF THE REPORTED "ABDOMINAL PAIN, SHORTNESS OF BREATH, LEFT FOOT NUMBNESS, DEPRESSION" IS 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.

    Description of Event or Problem · 1

    PLAINTIFF ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2013 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO DEEP VEIN THROMBOSIS. PLAINTIFF IS ALLEGING DEVICE UNABLE TO BE RETRIEVED, HOWEVER RECORDS PROVIDED INDICATE THE DEVICE WAS SUCCESSFULLY RETRIEVED ON (B)(6) 2014. PLAINTIFF IS ALLEGING TO HAVE EXPERIENCED ABDOMINAL PAIN, SHORTNESS OF BREATH, LEFT FOOT NUMBNESS AND DEPRESSION.

    Description of Event or Problem · 1

    PATIENT RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2013 AS PER INTERVENTIONAL RADIOLOGY REPORTS AS WELL AS SPECTRUM HEALTH PROGRESS NOTES AND NOT (B)(6) 2013 AS PREVIOUSLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345841 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC G33016 2825058 10827002330167

    Patients

    Seq Age Sex Outcome Treatment
    1 Other