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); Structural Problem (2506); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Erosion (1750); Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Sleep Dysfunction (2517); No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this report indicate information is unknown or unavailable.(b)(4).Event is still under investigation at this time.

Event Description

It is alleged that "[pt] received a gunther tulip filter on (b)(6) 2007." 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

(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

It is alleged that "[pt] received a gunther tulip filter on (b)(6) 2007." 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

(b)(4).Mdr decision tree updated from product malfunction to serious injury/life threatening based on additional documentation provided.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information was received on 11/17/2016 as follows: the plaintiff allegedly received device implant via right femoral vein on (b)(6) 2007 due to dvt in left lower extremity.The plaintiff alleges device migration, device is unable to be retrieved, filter erosion into spine causing pain after implant of device.

Manufacturer Narrative

Correction(s): added pain.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, migration, unable to retrieve, in spine, filter erosion, lower back pain'.Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.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.Unknown if the reported lower back pain is directly related to the filter and unable to identify a corresponding failure mode at this time.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

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation: the following allegations have been investigated: organ(l3 vertebrae) penetration, vena cava (vc) perforation, physical limitations, sleeping issue.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The additional information regarding organ penetration/vena cava perforation does not change the previous investigation for perforation.Unknown if the reported physical limitations and sleeping issue are directly related to the filter and unable to identify a corresponding failure mode at this point in time.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 report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Patient is additionally alleging vena cava perforation and penetration of l3 vertebral body.Patient notes and further alleges experiencing "cannot stand or sit for long periods of time and difficulty sleeping at night", physical limitations.Per the 04dec2018 computed tomography (ct) abdomen without contrast: "impression: the tip of the ivc filter is located above the level of the right renal vein.Four struts of the filter extend beyond the ivc wall, and the left posterolateral strut erodes into the adjacent l3 vertebral body".

• 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
• MDR Report Key: 6169951
• MDR Text Key: 62265079
• Report Number: 1820334-2016-01523
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K043509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IGTCFS-65-FEM
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/23/2016
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Weight: 84