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

Catalog Number IGTCFS-80-JUG

Device Problems Structural Problem (2506); Device Tipped Over (2589); Material Twisted/Bent (2981); Insufficient Information (3190)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Internal Organ Perforation (1987); Perforation of Vessels (2135); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Occupation: non-healthcare professional.Catalog number and lot number are unknown; however, 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.It has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

It is alleged that the patient received a gunther tulip ivc filter device on (b)(6) 2006.It is alleged that the patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Event Description

Patient allegedly received an implant on (b)(6) 2006 via the right internal jugular vein due to pulmonary embolism(pe) and deep vein thrombosis (dvt), trauma -tibia/fibula fractures, and status post motor vehicle accident.The patient alleges tilt, organ-mesenteric/vena cava perforation, bent strut, and embedment.The patient further alleges anxiety, mental anguish, and stress.(b)(6) 2017 , per a report from computed tomography; ¿conclusion: there are perforations of the wall of the inferior vena cava by the lager struts of the inferior vena cava filter.No other significant abnormalities were otherwise identified with no participation of the process in any of the surrounding structures of the inferior vena cava.The tip of the inferior vena cava filter is angled posteriorly, in contact with the with a posterior wall of the vessel.¿.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The following fields were updated per additional information received: a2, a4, b2, b5, b6, b7, d1, d4, h4 and h6.Investigation.The following allegations have been investigated: organ-mesenteric/vena cava perforation, embedment, tilt, bent strut, anxiety/mental anguish/stress.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.Unknown if the reported bent strut, anxiety/mental anguish, and stress are directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of 10 devices were manufactured in the reported lot.To date, no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to current controls 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.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, or that any cook device caused or contributed to or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 9197211
• MDR Text Key: 168219318
• Report Number: 1820334-2019-02615
• 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
• Report Date: 09/16/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2008
• Device Catalogue Number: IGTCFS-80-JUG
• Device Lot Number: 1480875
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 08/27/2020
• Supplement Dates FDA Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Weight: 88