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

Catalog Number UNKNOWN

Device Problems Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Nausea (1970); Pain (1994); Perforation of Vessels (2135); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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) 2005.It is alleged that the patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

(b)(4).Corrected data based on new information received: adverse event to product malfunction.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 07/14/2017 as follows: patient allegedly received an implant on (b)(6) 2005 via the right internal jugular vein due to gastric bypass surgery, venous insufficiency.Patient is alleging vena cava perforation, stomach pain, nausea and anxiety due to the device.Patient alleges that the device is tilted.

Manufacturer Narrative

Correction: implant date.Additional information: 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, vc perforation, stomach pain, nausea, anxiety, tilt'.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.Unknown if the reported stomach pain, nausea, anxiety 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

Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Therefore, no new investigation activities will be conducted at this time.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

Per lumbar spinal ct, dated (b)(6) 2012, "there is an inferior venocaval filter in place.The tip of the filter appears to be either embedded or possibly even perforated through the right lateral ivc wall with no clinical relevance as there is no adjacent hematoma.At least 3 legs of the filter have perforated through the ivc wall but these do not appear to have punctured and critical structures.This is a very common finding with this filter and a vast majority of protruding components cause no clinical symptoms and do not need to be addressed.".

• 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: 6608421
• MDR Text Key: 76536222
• Report Number: 1820334-2017-01389
• 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
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2019
• 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: 57