MAUDE Adverse Event Report: COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Pain (1994); Vomiting (2144); No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 07/01/2007

Event Type  malfunction  

Manufacturer Narrative

Patient age at time of event is currently unknown.Patient sex at time of event is currently unknown.Date of event requested but not provided.Lot # requested but not provided.User facility information is currently unknown as this information was not provided.(b)(4).Device manufacture date is currently unknown as information was not provided.Investigation- no information regarding the event was provided to assist with the investigation.The investigation was based on the information received to date, and are closing the report until further information is received for investigation.It is impossible to comment on alleged injuries.No evidence to suggest a device failure.No conclusion could be drawn.

Event Description

It is alleged that patient received a cook gunther tulip filter on (b)(6) 2006.The filter was placed by dr.(b)(6) at (b)(6) hospital; (b)(6).It is alleged that patient was injured without further explanation.Patient is seeking punitive damages.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

(b)(4).Investigation - no information regarding the event has been 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.There is no evidence to suggest the device was not manufactured to specifications.No evidence to suggest a device failure.The evaluation will be reassessed when further information is available.

Event Description

It is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2006.The filter was placed by dr.(b)(6) at (b)(6) hospital; (b)(6).It is alleged that patient was injured without further explanation.Patient is seeking punitive damages.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

(b)(4).Instructions for filter retrieval are labeled in the ifu.The event is currently under investigation.A supplemental report will be submitted upon completion.

Event Description

Additional information received (b)(6) 2017: it is alleged in the pending lawsuit that pt suffers from migration and the inability to retrieve the device.

Manufacturer Narrative

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

Event Description

This additional information received on 03/15/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2006 via the right common femoral vein due to le acute dvt, post-suicide attempt, multiple falls, poor candidate for anticoagulation, knee surgery.Plaintiff is alleging migration, device is unable to be retrieved, pain, nausea, vomiting.Plaintiff alleges attempted retrieval on (b)(6) 2007.

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 "pt suffers from vena cava perforation, the inability to retrieve the device, and other: straightening of hook during removal attempt" 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.According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e.G., the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu.

Event Description

Plaintiff allegedly received an implant on (b)(6) 2006 via the right common femoral vein due to le acute dvt, post-suicide attempt, multiple falls, poor candidate for anticoagulation, knee surgery.Plaintiff is alleging migration, device is unable to be retrieved, pain, nausea, vomiting.Plaintiff alleges attempted retrieval on (b)(6) 2006.

• Brand Name: GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
• 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: 5471099
• MDR Text Key: 39384212
• Report Number: 1820334-2016-00114
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043509
• 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: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IGTCFS-65-FEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Other
• Date Manufacturer Received: 06/25/2017
• Date Device Manufactured: 12/01/2008
• 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 Age: 60 YR
• Patient Weight: 68