MAUDE Adverse Event Report: COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G33017

Device Problems Short Fill (1575); Defective Component (2292); Structural Problem (2506)

Patient Problems Internal Organ Perforation (1987); Pain (1994); Thrombosis (2100); Perforation of Vessels (2135); Stenosis (2263); Anxiety (2328)

Event Type  Injury  

Manufacturer Narrative

The previous medwatch report was submitted by william cook europe under manufacturer report reference# 3002808486-2020-00090 additional information provided determined that this device was manufactured by cook inc.With the submission of this initial medwatch report, cook inc.Informs that all future submissions regarding this complaint will be handled under the manufacturer report reference.Blank fields on this form indicate the information is unknown, unavailable, or unchanged.(b)(6).Investigation the following allegations have been investigated: deep vein thrombus, caval thrombosis, pain, paralysis sensation, anxiety/worry, limited physical activity.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.Unknown if the reported pain, paralysis sensation, anxiety/worry, limited physical activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.No relevant notes on work order.The product is manufactured and inspected according to specifications.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

Patient allegedly received an implant on (b)(6) 2012 via the internal jugular vein due to post deep vein thrombosis (dvt) and pulmonary embolism (pe).Patient is alleging dvt and caval thrombosis.The patient further alleges pain, paralysis sensations, extreme anxiety and worry regarding damage it can cause and potential fatality, limited physical activity (lifting and strenuous exercise).22jan2016, per a report from computed tomography (ct); ¿findings: there is an inferior vena cava filter.There is no opacification of the inferior vena cava below the filter.There is also a filling defect noted within the right common iliac vein and also within the right common femoral vein extending into the superficial femoral vein.Impression: inferior vena cava filter in place.Nonopaclfication of the inferior vena cava and the right common iliac vein suggesting possible thrombus within these veins.Thrombus also noted within the right superficial femoral and common femoral veins which was also seen on prior venous doppler study from 10/2015.¿ 15jun2016, per a report from computed tomography (ct); ¿findings: inferior vena cava filter is noted in infrarenal location.The inferior vena cava is not opacified.The left common iliac, left external iliac and left common femoral veins appear patent.There appears to be a filling defect in the superficial femoral vein on the left and filling defect in the superficial femoral vein on the right which, however, may be mixing artifacts and not clearly characterized on this study.Impression: 4.Inferior vena cava filter in place with nonopacification of the inferior vena cava and right common iliac vein as noted previously suggesting possible thrombus within these veins.¿ 26jan2017, per a report from computed tomography (ct); ¿an ivc filter is present.There is incomplete filling of a very small infrarenal ivc.Right iliac veins also show incomplete opacification.These findings appear chronic.¿.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation: the following allegations have been investigated: organ/vena cava perforation, stenosis.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma.The additional information regarding stenosis does not change the previous investigation results for deep vein thrombosis/caval thrombosis.20 devices in lot.No relevant notes on work order.The product is manufactured and inspected according to specifications.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.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.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.

Event Description

The patient alleges vena cava perforation, organ perforation, and stenosis.06aug2019, per a report from computed tomography 2; ¿ivc filter with: 8 mm vertebral and 6 mm mesenteric perforation.Ivc stenosis.No fracture, migration, or tilting.¿.

• Brand Name: GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
• 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: 9801711
• MDR Text Key: 201064065
• Report Number: 1820334-2020-00566
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002330174
• UDI-Public: (01)10827002330174(17)150701(10)3556949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2015
• Device Model Number: G33017
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: 3556949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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: Female
• Patient Weight: 56 KG