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

Catalog Number UNKNOWN

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

Patient Problems Pulmonary Embolism (1498); Perforation of Vessels (2135); Stenosis (2263); 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) 2009.It is alleged that the plaintiff was injured without further explanation.Hospital and medical records have been requested but not yet provided.

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- tilt, vc perforation, pe, stenosis (occlusion), swelling of legs, pain, anxiety, anguish and stress." 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 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 swelling, anxiety, anguish, or stress is directly related to the filter and unable to identify corresponding failure mode(s) 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

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

Correction(s): implant date: to (b)(6) 2009.Explant date: (b)(6) 2009 to blank.

Event Description

This additional information received on 30jan2018 as follows: pt received an implant on (b)(6) 2009 via the femoral vein due to deep vein thrombosis.Pt is alleging tilt, vena cava perforation, perforation in the mesenteric and stenosis.Pt is further alleging post implant pulmonary embolism, swelling of legs and feet, discomfort in trunk and groin, abdominal pain, anxiety, anguish and stress.

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.(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: 7137513
• MDR Text Key: 95463377
• Report Number: 1820334-2017-04437
• 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,Followup
• Report Date: 03/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Weight: 89