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

Model Number G33016

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Pulmonary Embolism (1498); Perforation of Vessels (2135); Depression (2361)

Event Type  Injury  

Manufacturer Narrative

The previous medwatch report was submitted by william cook europe under manufacturer report reference# 3002808486-2019-01740.Additional information provided determined that this device was manufactured by cook inc.With the submission of this initial medwatch report, cook inc.Informs that all future submissions regarding this complaint will be handled under the manufacturer report reference # referenced in manufacturer report number of this initial medwatch report.Occupation: non-healthcare professional.(b)(4).Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: pulmonary embolism (pe), vena cava perforation, migration, tilt, "device plugged completely", depression, anxiety, limited physical activity.The reported allegations have been further investigated based on the information provided to date.New pe as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: pulmonary embolism.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 or filter fragment migration and (or) embolization (e.G., movement to the heart or lungs) has been reported.Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; 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: filter migration, trauma to adjacent structures.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 "device plugged completely", depression, anxiety, and limited physical activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.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 become available.

Event Description

Patient allegedly received an implant on (b)(6) 2014 via the right common femoral vein for prevention of deep vein thrombosis (dvt)/pulmonary embolism (pe).Patient is alleging migration, tilt, vena cava perforation, and pe.The patient is further alleging "device plug completely and [required] hospital for a proximate one month and treatment which required over 10 months.I can now walk less than 1 mile on level ground.", "i can drive at most 1 hour.", depression, and anxiety.It was further reported that a successful routine percutaneous filter removal was performed approximately 1 month after the filter implant.

Manufacturer Narrative

Investigation: investigation is reopened due to additional information provided.Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Therefore, no new investigation activities will be conducted at this time.A total of (b)(4) 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 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

No additional event information was received.

• 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 (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 9484519
• MDR Text Key: 182715295
• Report Number: 1820334-2019-03135
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002330167
• UDI-Public: (01)10827002330167(17)170101(10)4781787
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

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: 01/01/2017
• Device Model Number: G33016
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 4781787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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; Hospitalization
• Patient Sex: Male
• Patient Weight: 100 KG