BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 7365964 · Received March 23, 2018

    Report

    Report Number
    1820334-2018-00580
    Event Type
    Injury
    Date Received
    March 23, 2018
    Report Date
    April 1, 2018
    Manufacturer
    COOK INC
    Product Code
    DTK
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RPN IS UNKNOWN, DATE OF IMPLANT IS UNKNOWN, POTENTIAL 510K K073528 OR K161218. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE GIANTURCO-ROEHM BIRD¿S NEST VENA CAVA FILTERS ARE PLACED VIA STANDARD PERCUTANEOUS ENTRY (SELDINGER) TECHNIQUE. INTRODUCTION OF THE GIANTURCO-ROEHM BIRD¿S NEST FILTER IS ACCOMPLISHED THROUGH A SERIES OF CONTROLLED STEPS WHICH ALLOW THE OPERATOR TO ALTER PLACEMENT TO ACCOMMODATE ANATOMIC VARIATIONS. THE GIANTURCO-ROEHM BIRD¿S NEST FILTER¿S HOOK WIRE DESIGN AND TWO PAIR OF ¿V¿ SHAPED STRUTS HOLD THE FILTERING WIRES IN PLACE AND FACILITATES A SECURE FIXATION IN THE VENA CAVA WITH A MINIMAL RISK OF MIGRATION OR VESSEL PERFORATION. THE BIRD¿S NEST VENA CAVA FILTERS ARE INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM VIA PLACEMENT IN THE VENA CAVA. THE DEVICE IS SHIPPED WITH THE INSTRUCTIONS FOR USE (IFU) WHICH STATES, ¿IF FILTER MIGRATION OCCURS, TRANSCATHETER RETRIEVAL OF THE FILTER IS NOT RECOMMENDED.¿ DEFLECTION TESTING OF THE STRUTS WAS CONDUCTED AS PART OF DESIGN VERIFICATION TESTING. RESULTS OF THE DEFLECTION TESTING EXCEEDED THE ACCEPTANCE CRITERION OF THE TESTING. RISK TO BENEFIT ANALYSIS (RBA) RA82_RBA WAS PERFORMED IN ORDER TO ASSESS THE CLINICAL BENEFIT: RISK RATIO OF THE BIRD'S NEST FILTER AND THE RBA STATES: "'IT IS THE OPINION OF COOK INC. THAT THE MEDICAL BENEFITS OF THE BIRD'S NEST FILTER OUTWEIGH THE RESIDUAL RISK OF THE INTENDED USE OF THE DEVICE. THE BIRD¿S NEST VENA CAVA FILTERS HAVE BEEN FOUND TO DEMONSTRATE GOOD CLOT TRAPPING EFFICACY IN VITRO STUDIES. IN ADDITION, THIS DEVICE IS DESIGNED TO BE PLACED IN VENA CAVA DIAMETERS UP TO 40 MILLIMETERS, A MEASUREMENT THAT RESTRICTS SOME PATIENTS FROM THE USE OF OTHER DEVICES." IT IS CONCLUDED THAT THESE DEVICES MEET THE PERFORMANCE REQUIREMENTS NECESSARY TO PERFORM THEIR INTENDED USE SAFELY AND EFFECTIVELY. 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, "BIRD'S NEST FILTER THAT HAS FRACTURED AND MIGRATED. PARTS OF THIS DEVICE IS STICKING IN MY ABDOMINAL AORTA, PART IS STICKING IN MY RENAL VEIN, AND THE REST IS SPREAD THROUGHOUT MY BODY." COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. 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

    AS REPORTED PER MW 5067888: " I WOULD LIKE TO FILE A FORMAL COMPLAINT WITH THE FDA. I HAVE A COOK MEDICAL IVC BIRD'S NEST FILTER THAT HAS FRACTURED AND MIGRATED. PARTS OF THIS DEVICE IS STICKING IN MY ABDOMINAL AORTA, PART IS STICKING IN MY RENAL VEIN, AND THE REST IS SPREAD THROUGHOUT MY BODY. I WOULD ALSO LIKE TO KNOW IF THERE HAS BEEN A RECALL ON THIS FILTER AS THE FDA ONLY ALLOWS REMOVABLE FILTER TO BE IMPLANTED FOR NO LONGER THAN 5 YEARS. 'IF SO WHY WAS I NEVER CONTACTED', I AM FILING THIS COMPLAINT WITH THE FDA AND DO NOT SIMPLY WANT THIS SENT TO COOK MEDICAL. I AM IN THE PROCESS OF GATHERING OTHER SAME WITH THE SAME PROBLEM AS MINE AND THEY WILL BE FILING A COMPLAINT ALSO IN ORDER TO GET A RECALL ISSUED IF ONE HAS NOT BEEN ALREADY ISSUED. LOOKING TO HEAR BACK FROM THE FDA AND NOT COOK MEDICAL. THANKS FOR YOUR HELP IN THIS MATTER". ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED. THE COMPLAINANT AND/OR USER FACILITY DETAILS ARE CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209413 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening