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

Catalog Number IGTCFS-65-1-FEM-TULIP

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

Patient Problems Perforation of Vessels (2135); Blurred Vision (2137); Dizziness (2194); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog# is unknown but referred to as cook gunther tulip filter.Occupation: non-healthcare professional.(b)(4).It has not been possible to investigate or evaluate this alleged 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

Description of event according to short form complaint filed: 'it is alleged that "pt received a cook gunther tulip filter on (b)(6) 2015".Patient outcome: it is alleged that pt was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Device code(s): appropriate term/code not available (3191) was selected for the alleged device perforation.Device code(s): appropriate term/code not available (3191) was selected for the alleged device tilt.This report includes information known at this time.A follow-up medwatch report will be submitted if 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.

Event Description

Patient allegedly received an implant on (b)(6) 2015 via the right femoral vein due to deep vein thrombosis (dvt) and pulmonary embolism (pe).Patient is alleging device tilt and strut perforation.Patient notes and also alleges experiencing "blurred vision, off balance, dizzy, memory loss, numbness".Per the ct abdomen without contrast dated (b)(6) 2019: ivc filter evaluation: "filter tilt: the ivc filter is tilted along the course of the patient's ivc.The apex of the filter is touching the posterior ivc wall.Abnormal positioning of the ivc filter: the ivc filter tip is located below the lowest renal vein and not greater than 2 cm below the lowest renal vein.Perforation beyond the ivc wall with or without involvement of an adjacent organ/vessel: the anterior left and right filter struts extend 4 mm beyond the wall of the ivc, both touching the adjacent third portion of the duodenum without appearing to extend through the wall.Filter strut fracture or bending: no fractured or bent strut fragments identified.Stenosis of the inferior vena cava: no ivc stenosis identified by noncontrast ct".

Manufacturer Narrative

Investigation is reopened due to additional information provided.The following allegations have been investigated: strut perforation, tilt, blurred vision, off-balance, dizziness, memory loss, and numbness.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 blurred vision, off-balance, dizziness, memory loss, and numbness 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 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 to provide at this time.

• Brand Name: GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8715985
• MDR Text Key: 148535286
• Report Number: 3002808486-2019-00760
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• Device Catalogue Number: IGTCFS-65-1-FEM-TULIP
• Device Lot Number: E3381132
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/29/2019
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 88