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

Model Number N/A

Device Problems Other (for use when an appropriate device code cannot be identified) (2203); Insufficient Information (3190)

Patient Problems Internal Organ Perforation (1987); Perforation (2001); Perforation of Vessels (2135)

Event Date 02/06/2013

Event Type  Injury  

Event Description

Complaint received via lawsuit-complaint received by (b)(6).The allegations of their lawsuit are: on or about (b)(6) 2005, the pt presented and was diagnosed with left lower extremity deep vein thrombosis.It was determined that she would be implanted with a temporary/retrievable ivc filter known as the gunther tulip vena cava filter.The filter was inserted into the pt.There were no complications at the time of implantation.On or about (b)(6) 2011, the pt presented for a ct scan at which point it was discovered that the limbs of the filter had penetrated through the vena cava into the surrounding retroperitoneal fat.On and off over the next couple of years, the plaintiff experienced shortness of breath, chest pains, and other sharp stabbing pain that was associated with the perforated limbs of the filter.The filter was successfully removed in (b)(6) 2013.No add'l info has been provided.

Manufacturer Narrative

Additional device info: expiration: unk as lot is unk.(b)(4).Pma/510k number: unk as catalog number is unk.Event eval: still under investigation.

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 "vena cava perforation, organ perforation, updated sfc." 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.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.

Manufacturer Narrative

(b)(4).Corrected data based on new information received: (b)(6).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information was received on 04/15/2015 as follows: plaintiff allegedly received an implant on (b)(6) 2005 via the right common femoral vein due to dvt.The plaintiff had a successful filter retrieval procedure performed on (b)(6) 2013.Plaintiff is alleging vena cava perforation, organ perforation.

Manufacturer Narrative

As no device, imaging studies, hospital or medical records have been available, the investigation is limited to the allegations in the litigation.Event description: on or about (b)(6) 2005, the patient presented and was diagnosed with left lower extremity deep vein thrombosis it was determined that she would be implanted with a temporary/retrievable ivc filter, known as the gunther tulip vena cava filter.The filter was inserted into the patient.There were no complications at the time of implantation.On or about (b)(6) 2011, the patient presented for a ct scan, at which point, it was discovered that the limbs of the filter had penetrated through the vena cava into the surrounding retroperitoneal fat.On and off, over the next couple of years, the plaintiff experienced shortness of breath, chest pains, and other sharp stabbing pain that was associated with the perforated limbs of the filter.The filter was successfully removed in (b)(6) 2013.The facility that placed and removed the filter is unknown.Shortness of breath, chest pains, and other sharp stabbing pain.Removal of filter post perforation.Consequently, based on very limited information, it is difficult to comment on the alleged filter perforation into the surrounding retroperitoneal fat and the shortness of breath, chest pains, and other sharp stabbing pain that was associated with the alleged perforated limbs of the filter.During the course of investigation, reviews of the complaint history and of the instructions for use (ifu) were conducted.The rpn and lot number were not provided, therefore, the device history record cannot be investigated.However, nothing indicates the device was not manufactured according to specification.The instructions for use (ifu) list damage to the vena cava and vena cava perforation as potential adverse events.Such events have also been reported in the published medical and scientific literature.A reference is made to the instructions for use.In potential adverse events are mentioned.Damage to the vena cava, pulmonary embolism, filter embolization, vena cava perforation, vena cava occlusion or thrombosis, hemorrhage, extravasation of contrast material at time of vena cavagram, hematoma at vascular access site, infection at vascular access site, thrombosis or stenosis at implant site, death.Based on the above information and investigation, the exact root cause for what caused the alleged filter perforation into the surrounding retroperitoneal fat is unknown.We will continue to monitor for similar complaints and have notified the appropriate internal personnel.Per the conclusion of quality engineering risk assessment (qera), further risk reduction will not be conducted at this time the medical benefit of prevention of recurrent pulmonary embolisms obtained by placing an ivc filter outweighs the residual risk of ivc perforation.

Event Description

Complaint received via lawsuit: complaint received by (b)(6).The allegations of their lawsuit are on or about (b)(6) 2005, the patient presented and was diagnosed with left lower extremity deep vein thrombosis.It was determined that she would be implanted with a temporary/retrievable ivc filter known as the gunther tulip vena cava filter.The filter was inserted into the patient.There were no complications at the time of implantation.On or about (b)(6) 2011, the patient presented for a ct scan at which point it was discovered that the limbs of the filter had penetrated through the vena cava into the surrounding retroperitoneal fat.On and off over the next couple of years, the plaintiff experienced shortness of breath, chest pains, and other sharp stabbing pain that was associated with the perforated limbs of the filter.The filter was successfully removed in (b)(6) 2013.No additional information has been provided.

• 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; p.o. box 489; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3889123
• MDR Text Key: 4424916
• Report Number: 1820334-2014-00245
• 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: Other,consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/14/2014,08/03/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IGTCFS-45-FEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/11/2011
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/19/2014
• Initial Date FDA Received: 06/12/2014
• Supplement Dates Manufacturer Received: 07/26/2017; 07/26/2017; 07/26/2017
• Supplement Dates FDA Received: 03/11/2015; 06/25/2017; 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2005
• 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: 56 YR
• Patient Weight: 76