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

Catalog Number UNKNOWN

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Insufficient Information (3190)

Patient Problems Pain (1994); Perforation of Vessels (2135); Palpitations (2467); No Information (3190)

Event Date 10/09/2014

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) 2003.It is alleged that the patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Unknown if the following patient and device codes are listed in the ifu.Product information not provided.Corrected data based on new information received: adverse event to product problem.Serious injury to malfunction.The event is currently under investigation.A supplemental report will be provided upon conclusion.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.Other text : unknown if the following patient and device codes are listed in the ifu.Product information not provided.(b)(4) corrected data based on new information received: adverse event to product problem.Serious injury to malfunction.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information was received on 06/16/2017 as follows: the plaintiff allegedly received the filter implant on (b)(6) 2003 due to dvt following a motor vehicle accident.Unsuccessful retrieval attempts allegedly occurred on (b)(6) 2014, (b)(6) 2015.The plaintiff alleges vena cava perforation, migration, device unable to be retrieved, heart palpitations, and pain.

Manufacturer Narrative

Additional information: 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; migration; device unable to be retrieved; heart palpitations; pain'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.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 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.Unknown if the reported heart palpitations, depression and pain is directly related to the filter and unable to identify corresponding failure mode(s) at this time.There is 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

The pt allegedly received the filter implant on (b)(6) 2003 due to deep vein thrombosis (dvt) following a motor vehicle accident.Unsuccessful retrieval attempts allegedly occurred on (b)(6) 2014.The plaintiff alleges vena cava perforation, migration, device unable to be retrieved.The pt further alleges, depression, heart palpitations, and pain.

• 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: 6615486
• MDR Text Key: 76819165
• Report Number: 1820334-2017-01336
• 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
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/06/2017
• Supplement Dates Manufacturer Received: 06/16/2017; 12/27/2017
• Supplement Dates FDA Received: 07/07/2017; 01/22/2018
• 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 Age: 43 YR
• Patient Weight: 73