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

Catalog Number IGTCFS-65-UNI

Device Problem Occlusion Within Device (1423)

Patient Problems Pain (1994); Thrombosis (2100)

Event Type  malfunction  

Manufacturer Narrative

William cook europe initially reported event under manufacturer report #: 3002808486-2018-00483.New information was received identifying that the product was a cook inc.(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 05/01/2018 as follows: pt allegedly received an implant on (b)(6) 2018 via the right internal jugular vein due to chronic right leg deep vein thrombosis, unable to be anticoagulated secondary to brain hemorrhage.Pt is alleging occlusion and recurrent deep vein thrombosis.Pt.Further alleges general pain, mental anguish and deep vein thrombosis after implant.

Event Description

No additional information provided.

Manufacturer Narrative

Additional information: investigation: 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, occlusion, dvt, pain, mental anguish'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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 pain/discomfort is directly related to the filter.Unknown if the reported mental anguish is directly related to the filter and unable to identify corresponding failure mode(s) at this time.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 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

Additional information: investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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.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 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.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

No additional information provided at this time.Per ct, 12apr2013: " occlusive versus near occlusive thrombus in the inferior vena cava filter.A nonocclusive thread of thrombus extends approximately 1cm superiorly from the superior tip of the filter.".

• Brand Name: GUNTHER TULIP JUGULAR & FEMORAL 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: 7554472
• MDR Text Key: 109764047
• Report Number: 1820334-2018-01640
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2014
• Device Catalogue Number: IGTCFS-65-UNI
• Device Lot Number: 3693054
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 88