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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problems Obstruction of Flow (2423); Structural Problem (2506)
Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Stenosis (2263)
Event Type  Injury  
Manufacturer Narrative

The patient also reports having a tulip filter implanted, addressed in manufacturer report # 1820334-2021-01071. Occupation: non-healthcare professional. Investigation: this event has been investigated based on the information provided to date. 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. Cook also reviewed product labeling and instructions for use. Risk benefit analysis (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. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.

 
Event Description

Patient allegedly received a cook bird's nest inferior vena cava (ivc) filter on (b)(6) 2004. Patient is alleging stenosis and mesenteric perforation. Report from ct (computed tomography): "a bird's nest ivc filter is in place. The filter mesh extends approximately 2 cm above the renal veins. The tip of the most cephalad strut lies 5 mm above the renal veins. " "ivc stenosis is noted above the l4 level. Approximately 1. 3 cm strut perforation of the bird's nest filter is noted along the medial aspect of the ivc, 1 cm below the left renal vein. No definite strut fracture is identified. ".

 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key12312053
MDR Text Key266166441
Report Number1820334-2021-01967
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 08/12/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/12/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/12/2021 Patient Sequence Number: 1
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