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

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.".

Event Description

Patient is alleging vena cava perforation.

Manufacturer Narrative

The patient also reports having a tulip filter implanted, addressed in manufacturer report # 1820334-2021-01071.Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The following fields were updated per additional information received: b5, h6.Additional information: investigation per updated information received from the customer on (b)(6) 2022, the vena cava was perforated.No changes to the investigation have been made.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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, or that any cook device caused or contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 12312053
• MDR Text Key: 266166441
• Report Number: 1820334-2021-01967
• 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: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• 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: 03/09/2022
• 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): Life Threatening
• Patient Sex: Male