MAUDE Adverse Event Report: COOK INC UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number N/A

Device Problems Difficult to Remove (1528); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Pain (1994); Thrombosis (2100); Perforation of Vessels (2135)

Event Type  Death  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.

Event Description

It is alleged that, "[pt] received a gunther tulip filter on (b)(6) 2007.It is alleged that the patient had expired (date of death unknown) without further explanation.Hospital and medical records have been requested but not yet provided.

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 (b)(6) 2018 as follows: pt allegedly received an implant on (b)(6) 2007 to prevent deep vein thrombosis.Pt is alleging vena cava perforation, device unable to be retrieved.Pt.Further alleges constant pain in groin and leg, filter caused further clotting and a large thrombus within the left atrial appendage requiring prosthetic replacement.Left foot was removed due to clotting.Pt expired on (b)(6) 2015 without further explanation, discovery is continuing.An unsuccessful retrieval attempt by transfemoral approach was performed on (b)(6) 2007.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable or unchanged.It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Unknown if reported patient death is related to filter.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

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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, "tulip, unable to retrieve (embedded), vc perf, clots/thrombus (removal of foot), pain, patient expired." cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Unknown if the reported patient death is related to the filter.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.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.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 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.

Event Description

No additional information provided at this time.

• Brand Name: UNKNOWN
• 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: 7123077
• MDR Text Key: 95023981
• Report Number: 1820334-2017-04470
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 12/22/2017; 02/12/2018; 03/21/2018; 10/08/2018
• Supplement Dates FDA Received: 01/08/2018; 03/14/2018; 04/04/2018; 10/19/2018
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 78