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

Catalog Number UNKNOWN

Device Problems Structural Problem (2506); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Pain (1994); Perforation of Vessels (2135); Dizziness (2194); Anxiety (2328); Depression (2361); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: non-healthcare professional.Investigation: in response to this incident, cook completed a review of the product dmr.Bird¿s nest filter with push button release lists the standard materials, dimensions and appearance criteria required to create the bird¿s nest filter.Bird¿s nest filter template gives a template of the appropriate size of assembly, length of wires and bend of angle for the filter struts.The complaint device was built to specifications, which frameworks the process prepping, soldering, cleaning, forming and curling the bird¿s nest.In-process inspection for uncurled filter of the bnf-pb states: - inspect all sections 100%, unless otherwise specified.Insure correct length center wire extending between the two middle cannulas.Inspection method: measure with meter stick, holding at proximal and distal soldered cannulas.Insure correct size wire has been used to assemble the filter as follows: verify outside diameter of wire used for center wires.Inspection method: level i, measure with micrometer or caliper.Verify outside diameter of wire used on outside of filter.Inspection method: level i, measure with micrometer or caliper.Verify outside diameter of wires used on distal and proximal end of filter.Inspection method: level i, measure with micrometer or caliper.Final inspection for gianturco-roehm bird¿s nest vena cava filter states that the individual should: 100% inspect all sections of the device unless otherwise specified.Inspect all steps 100% unless otherwise specified.Inspect at level 1 to verify the filter releases properly.Verify proximal end of filter exits smoothly and completely.Verify curls of filter are appropriately formed.Verify smooth separation of filter.Verify filter has been previously inspected by visually examining the work order for subassembly work order number.Cook also reviewed product labeling.Contraindications, warnings and precautions for the bnf-40-pb gianturco-roehm bird's nest femoral vena cava filter.Potential adverse events include, but are not limited to: filter migration (may occur if proper anchoring techniques are not utilized).Inferior vena cava thrombosis.Perforation of vena cava wall.Hematoma at puncture site.Device history record (dhr) review: cook could not complete a review of the device history record (dhr) due to lack of lot information from the user facility.A database search for complaints on the affected lot could not be completed either.At this time, there is no evidence to suggest nonconforming product from the affected lot is in house or in the field.Conclusion 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.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) 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 medwatch report will be submitted if additional relevant information becomes available.

Event Description

It is alleged that the patient received a bird's nest inferior vena cava (ivc) filter on (b)(6) 2001, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.

Manufacturer Narrative

Investigation: 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) 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.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Patient allegedly received an implant on (b)(6) 2001 via the right common femoral vein due to surgery.Patient is alleging vena cava perforation and migration.Patient further alleges "pain, gastric issues, headaches and dizziness." depression and anxiety per report computed tomography, "caval perforation: yes.4 o'clock 6.40 mm grade 3 extending to the periphery of the abdominal aorta.4 o'clock inferiorly 10.70 mm grade 3 extending to the posterior periphery of the abdominal aorta.10 o'clock 6.80 mm grade 2.Note that this strut extends superior to the right renal vein.9 o'clock 3.60 mm grade 2." "migration: yes.The 10 o'clock strut extends above the right renal vein.".

• Brand Name: UNKNOWN
• Type of Device: DTK 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 Key: 14220585
• MDR Text Key: 290178371
• Report Number: 1820334-2022-00660
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Female
• Patient Weight: 177 KG