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

Catalog Number IGTCFS-45-FEM

Device Problems Fracture (1260); Malposition of Device (2616); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Pulmonary Embolism (1498); Perforation (2001); Disability (2371); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Occupation: non-healthcare professional.Investigation: 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.Catalog and lot# are unknown, however, the alleged tulip is manufactured and inspected according to specifications.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.

Event Description

It is alleged that the patient received a gunther tulip inferior vena cava (ivc) filter device on (b)(6) 2005.It is alleged that the patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: tilt, fracture, vc/muscle perforation, pain, bruising, pulmonary embolism, and disability.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 fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.Vena cava wall penetration/perforation has been reported and 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 pain is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Unknown if the reported bruising is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Unknown if the reported disability is directly related to the filter and unable to identify a corresponding failure mode at this point in time.No relevant notes on device or lot number.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.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.

Event Description

No additional information provided at this time.

Event Description

Additional information received identified the patient allegedly received a gunther tulip femoral vena cava filter implant on (b)(6) 2005 via the right femoral vein due to deep vein thrombosis and pulmonary embolism.The patient is alleging tilt, fracture, and muscle perforation.The patient further alleges, " being on a blood thinner due to the fracture of the inferior vena cava filter has changed my life forever.Normal activities such as shower or doing dishes could be life threatening to me.Additional back pain due to perforation of muscle by the inferior vena cava filter.Having to plan procedures every 6 months and go off oral blood thinner and having to inject lovenox twice a day for the time i'm off blood thinners in my abdomen.It causes bruising that is painful and leaves large knots in my abdomen that are painful".Additionally, patient alleges, "since the filter fractured and moved and i got a pulmonary embolism i have had to limit my activities such as rough housing with my grand kids, snowmobiling, 4-wheeling and swimming at the beach".It was also reported that per the (b)(6) 2019, computed tomography-abdomen without contrast: " inferior vena cava filter is in place with its tip abutting anterior left lateral wall.The tip is located about 1.4cm distal to the inferior vena cava and renal vein confluence.About 10-15 degree tilt to the inferior vena cava filter is noted.Extraluminal extension of the strut in the right iliopsoas muscle and adjacent retroperitoneal fat along the right side is observed.A 1.3cm linear density is demonstrated in the right psoas muscle at the level of l2-l3 intervertebral disc space suspicious for a fractured strut.The aorta demonstrates atherosclerotic calcification".

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Device codes: appropriate term/code not available (3191): perforation.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.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 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: 8568944
• MDR Text Key: 143690997
• Report Number: 1820334-2019-00917
• 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
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-45-FEM
• Device Lot Number: 1434537
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Weight: 103