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

Catalog Number IGTCFS-65-FEM

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Internal Organ Perforation (1987); Perforation (2001); Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

*** william cook europe initially reported event under mfr report # 3002808486-2016-00023.New information was received identifying that the product was a cook inc.Manufactured device.An updated emdr report was submitted under cook inc.Mfr report # 1820334-2016-00681, follow up # 1.This was in reference to william cook europe mfr report # 3002808486-2016-00023.Cook is now submitting an initial report to correct this issue.**** (b)(4).Evaluation- the product was not returned to assist with the investigation.No notes of relevance found in the device work order, nor on the filter lot number.No other complaints have been received relevant to this lot.Impossible to comment on the alleged injuries.Device manufactured/inspected according to specifications.There is no evidence to suggest the device was not manufactured to specifications.No evidence to suggest a device failure.We have notified appropriate personnel and will continue to monitor for similar events.If additional information is received, the report will be reopened for further investigation.

Event Description

It is alleged that patient received a cook gunther tulip filter on (b)(6) 2010 at (b)(6).It is alleged that the patient was injured without further explanation.Patient is seeking punitive damages.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Initial mdr was submitted by william cook europe under reference # 3002808486-2016-00023.Additional information provided on 07/06/2016 determined this device was manufactured by cinc.Evaluation: the product was not returned to assist with the investigation.No notes of relevance found in the device work order, nor on the filter lot number.No other complaints have been received relevant to this lot.Impossible to comment on the alleged injuries.Device manufactured/inspected according to specifications.There is no evidence to suggest the device was not manufactured to specifications.No evidence to suggest a device failure.We have notified appropriate personnel and will continue to monitor for similar events.If additional information is received, the report will be reopened for further investigation.

Event Description

It is alleged that patient received a cook gunther tulip filter on (b)(6) 2010 at (b)(6) health system.The filter was placed by dr.(b)(6).It is alleged that the patient was injured without further explanation.Patient is seeking punitive damages.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Acute damage to the inferior vena cava is listed as a potential adverse event in the ifu.(b)(4).The event is currently under evaluation.A supplemental report will be submitted upon completion.

Event Description

It is alleged that patient received a cook gunther tulip filter on (b)(6) 2010 at the (b)(6).It is alleged that the patient was injured without further explanation.Patient is seeking punitive damages.Hospital and medical records have been requested but not yet provided.Additional information received january 30, 2017: it is alleged in the pending lawsuit that pt suffers from vena cava perforation, the inability to retrieve the device, bleeding, organ perforation, and other: lupus coagulation present in blood; on blood thinners for lifetime.

Manufacturer Narrative

(b)(4).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.It has not been possible to fully investigate or evaluate this 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.

Event Description

Additional information received (b)(6) 2017: it is alleged in the pending lawsuit that pt suffers from vena cava perforation, the inability to retrieve the device, bleeding, organ perforation, and other: lupus coagulation present in blood; on blood thinners for lifetime.

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 02/01/2016 as follows: the plaintiff allegedly received the device implant on (b)(6) 2010 via right femoral vein due to pe, dvt, and as prophylactic arising from transfusion.Plaintiff is alleging organ perforation - duodenum, vena cava perforation, bleeding, pain, lupus coagulation, long term medications are required, device tilt, device is unable to be retrieved.

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 ¿organ perforation, vena cava perforation, tilt, device is unable to be removed".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.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.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.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.

• 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: 5834703
• MDR Text Key: 62602909
• Report Number: 1820334-2016-00681
• 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: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-FEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2017
• Date Device Manufactured: 02/01/2010
• 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: 104