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

Model Number N/A

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Aspiration/Inhalation (1725); Stenosis (2263); No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It is alleged the patient received a gunther tulip filter on (b)(6) 2008 at (b)(6) health system in (b)(6).It is alleged the patient was injured without further explanation.Patient is also seeing punitive damages.Medical records were requested, but have yet to be provided.

Manufacturer Narrative

(b)(4).It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

It is alleged the patient received a gunther tulip filter on (b)(6) 2008 at (b)(6) health system in (b)(6).It is alleged the patient was injured without further explanation.Medical records were requested, but have yet to be provided.

Manufacturer Narrative

(b)(4).510(k) # k032426.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information was received on 03/20/2017 as follows: the patient allegedly received the device implant via right internal jugular vein on (b)(6) 2008.The patient is alleging device tilt and shortness of breath.

Manufacturer Narrative

Product lot number.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 "tilt and shortness of breath".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e.G., the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu.It has not been possible to fully investigate or evaluate this event based on the limited information provided to date.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, or unavailable.Investigation - evaluation investigation is reopened due to additional information provided.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 'tulip, ivc occlusion / stenosis, tilt, shortness of breath, unable to retrieve (embedded), deep vein thromboss'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.A filter that is embedded in the wall of the ivc may be difficult to retrieve.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.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.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.Ivc stenosis as an outcome of cook ivc filters is reported in the published scientific literature.Ivc stenosis is characterized by smooth 25-50% narrowing of the ivc at the level of the indwelling filter.In an animal study ivc stenosis has been attributed to intimal thickening with focal fibrotic changes.Self-limiting and clinically silent ivc stenosis immediately after filter retrieval have also been reported and is most likely caused by vessel spasm.Ivc stenosis is documented by venography; it may be symptomatic or asymptomatic.Unknown if the reported shortness of breath (sob) is directly related to the filter.Unknown if the reported peripheral vein thrombosis is directly related to the filter and unable to identify a corresponding failure mode at this time.No other complaints on lot.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 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 provided at this time.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Patient code: vessel or plaque, device embedded in (1204)- not listed in the ifu, stenosis (2263)- listed in the ifu.Device code: difficult to remove (1528)-not listed in the ifu.Occupation: non-healthcare professional.(b)(4).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.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 an implant on (b)(6) 2008 due to blood clots.Patient is alleging device is unable to be retrieved, embedded device, and chronic occlusions/stenosis.Patient further alleges shortness of breath and chronic occlusions/stenosis.Unsuccessful retrieval attempt (b)(6) 2018 due to chronic right common iliac vein occlusion/stenosis.

• 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
• MDR Report Key: 6060167
• MDR Text Key: 58502420
• Report Number: 1820334-2016-01203
• 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,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2010
• Device Model Number: N/A
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: 1838104
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/25/2017; 08/30/2018; 10/18/2018
• Supplement Dates FDA Received: 02/14/2017; 04/11/2017; 07/12/2017; 09/20/2018; 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 136