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

Catalog Number IGTCFS-65-FEM

Device Problems Material Erosion (1214); Difficult to Remove (1528); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Occlusion (1984); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Patient and device code: no information regarding the event has been provided.The event is currently under investigation.A supplemental report will be submitted upon completion.

Event Description

It is alleged that [pt] received a cook gunther tulip on (b)(6) 2009 it is alleged that the patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

We have investigated based on the information received to date, and are closing the report until further information is received for investigation.No conclusion can be drawn based on the incomplete information provided on alleged injury.If additional information is received, the report will be re-opened for further investigation.

Manufacturer Narrative

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, thrombosis in filter, tilt, eroded, unable to retrieve'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.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).Corrected data based on new information received: type of reportable event: serious injury to malfunction.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 05/24/2017 as follows: patient received an implant on (b)(6) 2009 via the right common femoral vein due to deep vein thrombosis and pulmonary embolism.Patient is alleging device is unable to be retrieved.

• 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 Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6618540
• MDR Text Key: 76863767
• Report Number: 1820334-2017-01386
• Device Sequence Number: 1
• Product Code: DTK
• 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
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-FEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2008
• 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): Other
• Patient Weight: 122