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

Model Number N/A

Device Problems Difficult to Remove (1528); Device Issue (2379); Insufficient Information (3190)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It is alleged that the plaintiff received a gunther filter on (b)(6) 2010.It is alleged that the plaintiff was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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: patient gender corrected from female.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 12/07/2017 as follows: patient received an implant on (b)(6) 2010 via the right internal jugular vein due to acute left leg iliofemoral deep venous thrombosis with severe leg swelling and pain.Patient is alleging aorta perforation, pain, discomfort, filter failure and that the device is unable to be retrieved.No documentation regarding attempted retrieval was provided.

Manufacturer Narrative

Corrected data based on new information received: product lot number corrected.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

Patient received an implant on (b)(6) 2010 via the right internal jugular vein due to acute left leg iliofemoral deep venous thrombosis with severe leg swelling and pain.Patient is alleging , vena cava perforation, perforated aorta, pain, discomfort, filter failure and that the device is unable to be retrieved.No documentation regarding attempted retrieval was provided.

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 'tulip, vena cava + aorta perforation, unable to retrieve, pain, discomfort, filter failure'.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 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.Unable to determine if alleged pain and discomfort are related to the filter and unable to determine applicable failure mode.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.Product is manufactured and inspected according to specification.

• Brand Name: GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6976420
• MDR Text Key: 90209822
• Report Number: 1820334-2017-03669
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/16/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IGTCFS-65-JUG
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 10/25/2017
• Supplement Dates Manufacturer Received: 11/03/2017; 12/07/2017; 12/07/2017; 02/07/2018
• Supplement Dates FDA Received: 11/08/2017; 12/18/2017; 01/26/2018; 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 86