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); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987); Perforation (2001); Perforation of Vessels (2135)

Event Date 07/13/2012

Event Type  Injury  

Event Description

Per lawsuit filed, it is alleged that on or about (b)(6) 2008, plaintiff presented and was diagnosed with right iliofemoral vein thrombosis.The allegations of their lawsuit are: it was determined that a retrievable ivc filter be implanted.The gunther tulip vena cava filter was implanted.There were no complications at the time of implantation.On or about (b)(6) 2012, a ct scan was taken of the plaintiff's abdomen and pelvic, which is was first discovered that a metallic strut of the filter protruding into the third portion of the duodenum.The decision was made to remove the ivc filter.On or about (b)(6) 2012, plaintiff presented for surgery consisting of repair to their inferior vena cava to duodenal fistula with removal of the ivc filter and inferior vena cava litigation.During the removal procedure, it was noted that there were at least three different struts of the filter that had protruded into the duodenum and created a small leak.The filter was also discovered to be deeply embedded into the walls of the inferior vena cava.It was reported that the plaintiff had removal of the ivc filter and repair of the ivc to duodenal fistula.

Manufacturer Narrative

(b)(4).Investigation based solely on event description since no images and medical records are available.As no device, imaging studies or hospital or medical records have been available, the investigation is limited to the allegations in the ligation.Consequently, based on very limited information it is difficult to comment on the alleged filter perforation of duodenum causing duodenal fistula.The catalog number and lot number were not provided, why device history record cannot be investigated.However, nothing indicates the device was not manufactured according to specification.Tulip filter is manufactured and inspected according to specifications and drawings.Instructions for use 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; hematoma at vascular access site; infection at vascular access site; death.Based on the above, the exact root cause for what caused the filter alleged perforation of duodenum causing duodenal fistula is unknown.The appropriate internal personnel have been notified and we continue to monitor for similar events.No additional actions required at this time.Per qera, additional action is not required at this time based on the associated risk.

Manufacturer Narrative

(b)(4).

Event Description

Per lawsuit filed, it is alleged that on or about (b)(6) 2008, plaintiff presented and was diagnosed with right iliofemoral vein thrombosis.The allegations of their lawsuit are: it was determined that a retrievable ivc filter be implanted.The gunther tulip vena cava filter was implanted.There were no complications at the time of implantation.On or about (b)(6) 2012, a ct scan was taken of the plaintiff's abdomen and pelvis, which is was first discovered that a metallic strut of the filter protruding into the third portion of the duodenum.The decision was made to remove the ivc filter.On or about (b)(6) 2012, plaintiff presented for surgery consisting of repair to their inferior vena cava to duodenal fistula with removal of the ivc filter and inferior vena cava ligation.During the removal procedure, it was noted that there were at least three (3) different struts of the filter that had protruded into the duodenum and created a small leak.The filter was also discovered to be deeply embedded into the walls of the inferior vena cava.It was reported that the plaintiff had removal of the ivc filter and repair of the ivc to duodenal fistula.

Manufacturer Narrative

(b)(4).Event evaluation: a review of the device history, specifications and trends was conducted for the purpose of this investigation.As no device, imaging studies or hospital or medical records have been available, the investigation was limited to review of the device history record, specifications, and trends.There was no evidence to suggest that the device was not manufactured according to specifications, nor is there evidence of nonconforming/defective devices in house nor in the field.Based on very limited information it is difficult to comment on the alleged filter perforation of duodenum causing duodenal fistula.Instructions for use pamphlet (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.The device is supplied with instructions for use: the potential adverse events are mentioned: damage to the vena cava.Pulmonary embolism.Filter embolization.Vena cava perforation.Vena cava occlusion or thrombosis.Hemorrhage.Hematoma at vascular access site.Infection at vascular access site.Death.Based on the above, the exact root cause for what caused the filter alleged perforation of duodenum causing duodenal fistula is unknown.Per the conclusion of a risk assessment, 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.We will continue to monitor for similar complaints and have notified the appropriate internal personnel.

Event Description

Per lawsuit filed, it is alleged that on or about (b)(6) 2008, plaintiff presented and was diagnosed with right iliofemoral vein thrombosis.The allegations of their lawsuit are: it was determined that a retrievable ivc filter be implanted.The gunther tulip vena cava filter was implanted.There were no complications at the time of implantation.On or about (b)(6) 2012, a ct scan was taken of the plaintiff's abdomen and pelvis, which is was first discovered that a metallic strut of the filter protruding into the third portion of the duodenum.The decision was made to remove the ivc filter.On or about (b)(6) 2012, plaintiff presented for surgery consisting of repair to their inferior vena cava to duodenal fistula with removal of the ivc filter and inferior vena cava ligation.During the removal procedure, it was noted that there were at least three (3) different struts of the filter that had protruded into the duodenum and created a small leak.The filter was also discovered to be deeply embedded into the walls of the inferior vena cava.It was reported that the plaintiff had removal of the ivc filter and repair of the ivc to duodenal fistula.

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 04/15/2015 and is as follows: patient representative alleges that a cook gunther tulip filter was placed on (b)(6) 2008 for blood clots in thighs, legs.Patient representative alleges one successful attempt to retrieve the device on (b)(6) 2012.This was a surgical procedure under general anesthesia.It is alleged that the filter failed and was protruding through the vena cava wall and into the duodenum, allegedly causing gastrointestinal bleeding.Patient representative alleges that outcomes attributed to the device include: vena cava perforation and organ perforation (duodenum).Additional complaints include: stomach pain, stool problems, scar tissue, and chest 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, organ perforation - updated sfc".Cook will reopen its investigation if further information is received.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.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.

• Brand Name: GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3883915
• MDR Text Key: 4593671
• Report Number: 1820334-2014-00246
• 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: 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

• Date FDA Received: 06/13/2014
• 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-65-FEM
• 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
• Distributor Facility Aware Date: 05/16/2012
• Device Age: 4 YR
• Event Location: Hospital
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2007
• 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; Required Intervention
• Patient Age: 27 YR