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

Model Number G33017

Device Problems Obstruction of Flow (2423); Structural Problem (2506); Detachment of Device or Device Component (2907)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Anxiety (2328); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

The previous medwatch report was submitted by william cook europe under manufacturer report reference#3002808486-2021-01147.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 # referenced in this medwatch.Initial reporter occupation: non-healthcare professional.Investigation the following allegations have been investigated: mesenteric/vena cava (vc) perforation, thrombus, ivc occlusion, anxiety.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, vena cava perforation, vena cava penetration.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 anxiety is directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of (b)(4) devices were manufactured in the reported lot.To date, no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to current controls.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.

Event Description

Patient allegedly received an implant on (b)(6) 2014 via the right internal jugular vein due to post deep vein thrombosis (dvt).The patient alleges vena cava perforation.The patient further alleges anxiety.Please note, it is alleged the patient received another manufacturer's inferior vena cava (ivc) filter (b)(6) 2009 due to post dvt and pulmonary embolism (pe) which was reportedly removed (b)(6) 2014 (prior to cook gunther tulip placement) due to device failure.(b)(6) 2014, per a report from radiology; ¿no residual thrombus is identified in the leg or left pelvic system.There is ivc occlusion secondary to residual thrombus.This was successfully angioplastied with a 14 mm balloon.Final venogram demonstrates excellent flow from the left lower extremity through the ivc into a widely patent ivc filter.Residual thrombus in the ivc is mural in nature and off to the side and will likely resorbed with systemic anticoagulation.¿ (b)(6) 2014, per a report from ultrasound; ¿impression: filter in the inferior vena cava high in the abdomen as noted on the ct study with thrombus at that below the level of the filter with and incompletely occluded inferior vena cava at this level.¿ (b)(6) 2019, per a report from computed tomography; ¿ivc filter with: 5 mm mesenteric perforation.No tilting, fracture, migration, or stenosis.¿.

Manufacturer Narrative

Investigation: the following allegations have been investigated: fracture.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.(b)(4) 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

Patient allegedly received a gunther tulip filter on (b)(6) 2014 due to post deep vein thrombosis (dvt) followed by successful, percutaneous retrieval on (b)(6) 2021.The patient alleges fracture.Patient had a new celect inferior vena cava (ivc) filter placed (b)(6) 2021 in a suprarenal position due to chronic infrarenal caval thrombosis.On (b)(6) 2021, per a report x-ray; ¿fragmentation of the posterior medial leg of the suprarenal ivc filter, new from prior ct of (b)(6) 2021.Recommend further evaluation with ct of the abdomen and pelvis to better evaluate position of fragment and consider ir evaluation for filter removal/replacement given possible risk for migration.¿ on (b)(6) 2021, per a report from retrieval report (successful) and new celect filter placement; ¿the coaxial retrieval sheaths were advanced over the filter, successfully collapsing the filter away from wall of the vena cava.New ivc filter placement: the introducer sheath for a cook celect retrievable filter was subsequently advanced through the existing right jugular vascular access sheath.Due to chronic infrarenal caval thrombosis, suprarenal filter placement was deemed appropriate.¿ "impression: 1.Successful retrieval of intravenous foreign body (fracture ivc filter component).Successful retrieval of damaged inferior vena cava filter.Successful placement of ivc filter and suprarenal position due to chronic infrarenal caval thrombosis".

• 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: 12433932
• MDR Text Key: 270144287
• Report Number: 1820334-2021-02105
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002330174
• UDI-Public: (01)10827002330174(17)170101(10)4804838
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2017
• Device Model Number: G33017
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: 4804838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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: 120 KG