MAUDE Adverse Event Report: COOK INC GIANTURCO-ROEHM BIRD'S NEST JUGULAR VENA CAVA FILTER; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number BNF-75-PB

Device Problems Structural Problem (2506); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Chest Pain (1776); Internal Organ Perforation (1987); Perforation of Vessels (2135); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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 number are unknown, the device was described as a birds nest filter.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.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.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 filter on (b)(6) 2008 and was injured without further explanation.Hospital and medical records have been requested, but not yet provided.

Event Description

The patient received an implant on (b)(6) 2008 via the right common femoral vein to prevent blood clots after major surgery followed by open surgery/complex/laparotomy-right subcostal incision partial filter removal on (b)(6) 2018.The patient alleges migration, vena cava perforation, and organ perforation-gastrointestinal/bladder/aorta.The patient further alleges chest and stomach pain, bowel movement issues, chest/throat pressure, difficulty eating and swallowing, anxiety, mental anguish, stress, limited mobility, and worry.(b)(6) 2012, per a report from x-ray: ¿again incidentally noted is an ivc filter as well as multiple small metallic foreign bodies projecting over the right upper quadrant and right lower chest.¿ (b)(6) 2012, per a report from computed tomography: ¿probable ivc filter with extension of stress through the wall of the ivc, unchanged in appearance from the prior examination.¿ (b)(6) 2018, per a report from computed tomography: ¿infrarenal ivc filter is noted with extension of the right superior strut through the duodenal wall with tip in the duodenal lumen.Additionally both of the inferior struts extend through the ivc lumen with the inferior medial strut in close apposition to the aortic wall.The inferior lateral structure extends to the retroperitoneum anterior to the right ureter.¿ (b)(6) 2018 per a report from retrieval report: "retrieval and exposure of inferior vena cava and excision of extraluminal inferior vena cava filter and removal of filter from the duodenum".¿findings: partial removal of bird's nest ivc filter, strut in duodenum removed¿.

Manufacturer Narrative

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.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.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.

• Brand Name: GIANTURCO-ROEHM BIRD'S NEST JUGULAR VENA CAVA FILTER
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10967659
• MDR Text Key: 220212311
• Report Number: 1820334-2020-02259
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2009
• Device Catalogue Number: BNF-75-PB
• Device Lot Number: 1698221RX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Weight: 99