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

Model Number N/A

Device Problems Fracture (1260); Unintended Movement (3026); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Internal Organ Perforation (1987); Perforation of Vessels (2135); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It is alleged that the plaintiff received a gunther filter on (b)(6) 2008.It is alleged that the plaintiff was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

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, ¿gunther tulip filter implanted." cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Product is manufactured and inspected according to manufacturing instructions and quality control.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

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, fracture (leg in situ), tilt, vc + organ perforation, difficult to retrieve (embedded), anxiety'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.Filter fracture is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Fracture of a filter leg can be due to repetitive motion on a filter leg in an unusual stressed position.Among other causes, filter fracture may be associated with a filter leg perforating the ivc, a filter leg being caught in a side branch (e.G.Renal vein), 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.It has been reported that retrieval of a fractured filter or filter fragments using endovascular techniques is possible.Fracture of the wire is a known risk in relation to an implanted filter and reported in the published scientific literature.It is known from the published scientific literature that a filter fragment embolized into the heart or lung may be safely retrieved.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.Unknown if the reported anxiety is directly related to the filter and unable to identify corresponding failure mode(s) at this time.Rpn and lot# are unknown, but the tulip filter 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.

Event Description

This additional information received on 1feb2018 as follows: ¿[pt] allegedly received an implant on (b)(6) 2008 via the right common femoral vein due to deep vein thrombosis, pulmonary embolism, patient to undergo surgery.[pt] is alleging tilt, vena cava perforation, fracture, organ perforation, perforation to the mesentery, and embedment.[pt] further alleges anxiety.There are no filter retrieval attempts.

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.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7124953
• MDR Text Key: 95159773
• Report Number: 1820334-2017-04447
• 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,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other