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

Model Number N/A

Device Problems Difficult to Remove (1528); Filtration Problem (2941); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Internal Organ Perforation (1987); Pain (1994); Perforation (2001); Perforation of Vessels (2135); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event is currently under investigation.

Event Description

It is alleged that "[pt] received a cook gunther tulip on (b)(6) 2015 at (b)(6).Dr.(b)(6) placed the filter".Alleged "punitive damages, breach of express warranty, breach of implied warranty, law prohibiting consumer fraud and unfair and deceptive trade practices, loss of consortium".Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

(b)(4).Investigation - no information regarding the event was provided.We have investigated based on the information received to date, and are closing the report until further information is received for investigation.Impossible to comment on alleged injuries.If additional information is received, the report will be re-opened for further investigation.

Event Description

It is alleged that "[pt] received a cook gunther tulip on (b)(6) 2015 (b)(6).Dr.(b)(6) placed the filter".Alleged "punitive damages, breach of express warranty, breach of implied warranty, law prohibiting consumer fraud and unfair and deceptive trade practices, loss of consortium".Hospital and medical records have been requested but not yet provided.

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 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.Additional information received february 23, 2017: it is alleged in the pending lawsuit that pt suffers from vena cava perforation, the inability to retrieve the device, bleeding, and organ perforation.

Manufacturer Narrative

It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.

Manufacturer Narrative

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

Event Description

This additional information was received on 08jun2016 as follows: plaintiff allegedly received an implant on (b)(6) 2015 via the jugular vein due to hernia repair/dvt.Plaintiff is alleging vena cava perforation, device is unable to be retrieved, bleeding, organ perforation, pain from surgery incision.Plaintiff is alleging attempted retrieval on (b)(6) 2015 and successful retrieval on (b)(6) 2015.

Manufacturer Narrative

Evaluation- 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 " vena cava perforation, inability to retrieve" cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter perforation of the vena cava wall is a known risk reported in the published scientific literature.Also, published scientific literature describes that manipulation in the area of filter placement could contribute to changes to the filter configuration and placement thereby potentially initiate perforation of the vena cava wall.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 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.From the published scientific literature filter tilt inside ivc and/or embedment of filter legs or filter hook in the ivc wall is a well-known risk.Several case reports published in articles, describe successful retrievals of such filters by advanced retrieval techniques.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.

• Brand Name: UNKNOWN
• 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: 5405134
• MDR Text Key: 37335707
• Report Number: 1820334-2016-00049
• 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,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• 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
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Other
• Patient Weight: 98