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

Catalog Number IGTCFS-65-FEM

Device Problem Unintended Movement (3026)

Patient Problems Syncope (1610); Dyspnea (1816); Thrombosis (2100); Thrombus (2101)

Event Type  malfunction  

Manufacturer Narrative

William cook europe initially reported event under manufacturer report #3002808486-2017-01522.New information was received identifying that the product was a cook inc.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

Patient received an implant on (b)(6) 2012 via the right common femoral vein due to lower extremity thrombosis and pulmonary embolism.Patient had shortness of breath, syncope, fatigue, low blood pressure, device was tilted, and contained thrombus above, below and within; patient is alleging embedment; the device was allegedly retrieved on (b)(6) 2016.A second filter, cook celect, was implanted on (b)(6) 2016, related mfr# 3002808486-2017-01523.

Manufacturer Narrative

Additional information: 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.Pe is a known risk in relation to filter implant reported in the published scientific literature.Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins.With all filters, there is some risk of further pulmonary embolism.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

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, dyspnea, ivc occlusion, potential pe, syncope, fatigue, low bp, tilt, unable to ret (emb'd), dvt'.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.Pe is a known risk in relation to filter implant reported in the published scientific literature.Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins.With all filters, there is some risk of further pulmonary embolism.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 dyspnea, syncope, fatigue and low bp are 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.Lot# is unknown, but the device (igtcfs-65-fem) and tulip filter are 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.

Event Description

Pt further alleges deep vein thrombosis post-implant.

Manufacturer Narrative

Corrected data: lot number.Patient code: thrombosis (2100) listed in the ifu.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.

• 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
• MDR Report Key: 6854681
• MDR Text Key: 85626553
• Report Number: 1820334-2017-02514
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K043509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-FEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 113