BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 10190966 · Received June 24, 2020

    Report

    Report Number
    1820334-2020-01183
    Event Type
    Injury
    Date Received
    June 24, 2020
    Report Date
    June 24, 2020
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER OCCUPATION: NON-HEALTHCARE PROFESSIONAL. INVESTIGATION: IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE PATIENT ALLEGATION. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. WHILE THE CATALOG NUMBER AND LOT NUMBERS ARE UNKNOWN THE DEVICE WAS DESCRIBED AS A BIRDS NEST FILTER. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. 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 IN THE FOLLOWING SITUATIONS: PULMONARY THROMBOEMBOLISM WHEN ANTICOAGULANTS ARE CONTRAINDICATED, FAILURE OF ANTICOAGULANT THERAPY IN THROMBOEMBOLIC DISEASES, EMERGENCY TREATMENT FOLLOWING MASSIVE PULMONARY EMBOLISM WHERE ANTICIPATED BENEFITS OF CONVENTIONAL THERAPY ARE REDUCED, PROPHYLACTICALLY IN PATIENTS WITH CHRONIC, RECURRENT PULMONARY EMBOLISM WHERE ANTICOAGULANT THERAPY HAS FAILED OR IS CONTRAINDICATED. RISK BENEFIT ANALYSIS (RBA) RA82_RBA WAS COMPLETED TO ASSESS THE BENEFIT; RISK RATIO OF THE BIRD'S NEST FILTER. THE RBA STATES THAT "IT IS THE OPINION OF COOK INC. THAT THE MEDICAL BENEFITS OF THE BIRD'S NEST FILTER OUTWEIGH THE RESIDUAL RISKS TO THE PATIENT. IT IS EXPECTED THAT SOME PATIENTS WITH INDWELLING IVC FILTERS MAY STILL EXPERIENCE PULMONARY EMBOLI (THOUGH NOT NECESSARILY FATAL EMBOLI). A LITERATURE SEARCH FOR RELEVANT CLINICAL STUDIES SUGGESTS THAT PE RATE OF 1 TO 2 PERCENT IN PATIENTS WITH INDWELLING IVC FILTERS; IN THE BIRD'S NEST FILTER CLINICAL STUDY UPON WHICH THE FDA APPROVAL WAS BASED, 1% OF PATIENTS WITH A BIRD'S NEST FILTER EXPERIENCED PE. THE RATES OF PE REFLECTED IN OUR COMPLAINTS DATA IS SIGNIFICANTLY BELOW THE EXPECTED RATE OF PE. IT IS CONCLUDED THAT THESE DEVICES MEET THE PERFORMANCE REQUIREMENTS NECESSARY TO PERFORM THEIR INTENDED USE SAFELY AND EFFECTIVELY. 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.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE PATIENT RECEIVED A BIRD'S NEST FILTER ON AN UNKNOWN DATE. IT IS ALLEGED THAT THE PATIENT 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
    653004 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other