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

Model Number G33016

Device Problems Difficult to Remove (1528); Obstruction of Flow (2423); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Edema (1820); Occlusion (1984); Stenosis (2263); Pressure Sores (2326); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2011.It is alleged that the plaintiff was injured without further explanation.Hospital and medical records have been requested but not yet provided.

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 operative note stating ¿migration, tilt, unable to retrieve, vc & organ perforation, discomfort, ivc occlusion, dvt".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature.Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging or venography; this may be symptomatic or asymptomatic.Unknown if the reported discomfort is directly related to the filter.Unknown if the reported dvtis directly related to the filter and unable to identify a corresponding failure mode at this point in time.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.

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

This additional information received on 28mar2018 as follows: pt allegedly received an implant on (b)(6) 2011 via the right femoral vein due to motor vehicle accident with spinal cord injuries.Pt alleges migration, tilt, device unable to be retrieved, portion of filter causing a defect in lumbar 3 vertebratae.Pt further alleges burning, pressure discomfort of l3 level, and chronic decubitus to lower extremity, occluded vena cava at level of filter due to filter tilting leading to lower extremity swelling and post dvt.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Corrected information omitted from previous report: a3, b1, b2, h1, h6 (patient and device codes).Additional information: b7.Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: lower extremity swelling, chronic decubitus.The reported allegations have been further investigated based on the information provided to date.Unknown if the reported lower extremity swelling, chronic decubitus are 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 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 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

No additional information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation: investigation is reopened due to additional information provided.Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Therefore, no new investigation activities will be conducted at this time.Cook will reopen the investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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 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

No new event information at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, b6, h6 investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: stenosis.The additional information regarding stenosis does not change the previous investigation results for inferior vena cava (ivc) occlusion.A total of 20 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 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

Per a computed tomography (ct) lumbar spine: "impression: 1.Mild degenerative change lumbar spine with stable appearance to an ivc filter struts extending into the inferior l3 vertebra.No acute lumbar vertebral pathology.Stable alignment"."the strut from the ivc filter is again seen projecting into the inferior l3 vertebra with adjacent reaction.No interval change since 2017.There is mild facet osteoarthropathy.No acute lumbar vertebral fracture"."ivc filter is similar in appearance with stenotic ivc and collateral vessels of the retroperitoneum".Per a ct abdomen/pelvis: "there is normal opacification of the common femoral, external and common iliac veins bilaterally.The distal superior vena cava below the level of the ivc filter is not opacified.There is opacification of the inferior vena cava above ivc filter.There are extensive collateral vessels communicating between the common iliac and renal veins and the inferior vena cava above the level of ivc filter.The ivc filter is in place with metallic struts exiting the ivc lumen.One of the metallic strut is extending into the right anterolateral lower part of the vertebra l3 creating a focal area of osteopenia/bony erosion surrounded by sclerosis the start is extending into the vertebral body approximately 1.2 cm"."impression: 1.Complete occlusion of the inferior vena cava distal to the ivc filter as detailed above.Extensive collaterals in the pelvis and lower abdomen which drain into the renal veins and the inferior vena cava above the ivc filter through the testicular veins.2.The ivc starts extending out of the ivc lumen.One of the start extending and penetrating into the vertebral body l3 with surrounding sclerosis as detailed above.This is similar to the previous study".

• Brand Name: GUNTHER TULIP FEMORAL 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: 7348636
• MDR Text Key: 102738542
• Report Number: 1820334-2018-00630
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002330167
• UDI-Public: (01)10827002330167(17)140501(10)2744066
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G33016
• Device Catalogue Number: IGTCFS-65-FEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2022
• Date Device Manufactured: 05/01/2011
• 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; Other
• Patient Sex: Male
• Patient Weight: 109 KG