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

Catalog Number IGTCFS-65-FEM

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

Patient Problems Pain (1994); Perforation of Vessels (2135); Disability (2371); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Initial reporter is a non-healthcare professional.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

It is alleged that the patient received a gunther tulip inferior vena cava (ivc) filter device on (b)(6) 2007.It is alleged that the patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

H6-device codes: appropriate term/code not available (3191): perforation.Investigations: the reported allegations have been investigated based on the information provided to date.The following allegations have been investigated: tilt, perforation, back pain, vertigo, blood in urine, right side pain, anxiety, fear, and inability to lift objects over 30lbs.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 back pain is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Unknown if the reported vertigo is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Unknown if the reported blood in urine is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Unknown if the reported right side pain is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Unknown if the reported anxiety is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Unknown if the reported fear is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Unknown if the reported inability to lift objects over 30 lbs is 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 this lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to current controls.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.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

Additional information received identified the patient allegedly received a gunther tulip femoral vena cava filter implant on (b)(6) 2007 via the right common femoral artery due to recurrent deep vein thrombosis with a history of pulmonary embolus.The patient is alleging tilt and vena cava perforation.The patient further alleges, "back pain, vertigo, blood in urine, pain in right side of the body.I live with the anxiety of having a filter that could fail at any time, but that may not be retrievable without serious surgery.I live with fear, since my filter has tilted within my vena cava and has perforated outside of it.Can't lift objects over 30lbs ".

Event Description

Per a ct (computed tomography) scan of the abdomen dated (b)(6) 2017, "ivc filter is noted.There is no significant tilt.Several of the strut tips lie just outside the ivg wall by 5 mm.¿.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Corrected fields: d5.The following fields were updated per additional information received: b5, b6, h6.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.Cook will reopen the 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.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: 8531688
• MDR Text Key: 142494656
• Report Number: 1820334-2019-00867
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2019

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: 02/01/2010
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 04/19/2019
• Supplement Dates Manufacturer Received: 04/24/2019; 08/05/2019
• Supplement Dates FDA Received: 05/24/2019; 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Weight: 100