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 Dyspnea (1816); Perforation of Vessels (2135); Heart Failure (2206); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.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

'it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2014".It is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: a2, a4, b1, b5, b6, b7, d1, d4, g5, h4, h6 (patient and device codes) h6 (device code): appropriate term/code not available for device 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 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 allegedly received an implant on (b)(6) 2014 via the right common femoral vein due to pulmonary embolism (pe).Patient is alleging vena cava perforation.Patient notes and further alleges experiencing "heart failure, shortness of breath, i am weak and can't do many activities.Filter perforated my ivc".Patient notes "cannot walk more than one block".Per the inferior vena cava filter placement dated 09feb2014: description of procedure: "a venogram was performed which showed the cava to be patent and less than 3 cm in widest diameter.There was no evidence of thrombus in the cava".Findings: "filter in satisfactory intrarenal position".Per the 03apr2019 review of ct scan of abdomen and pelvis without iv or oral contrast dated (b)(6) 2019: "positive for caval perforation.Superior extent of ivc filter mid l1 vertebral body.Inferior extent l2-l3 disc space.A total of 4 prongs have perforated through ivc series 2 image 53.Maximum distance prongs perforated through ivc 7.54 mm series 2 image 53.Coronal images 7.31 degree tilt right to left series 3 image 61.Sagittal images 0.37 degree tilt anterior to posterior series 4 image 74.Diameter of ivc directly above filter 31.81 mm x 23.47 mm series 2 image 37".

Event Description

No additional information to provide at this time.

Manufacturer Narrative

Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: vena cava perforation, heart failure, shortness of breath, weakness, and limited physical ability.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.Unknown if the reported heart failure, shortness of breath, weakness, and limited physical ability 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.

• 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: 8715877
• MDR Text Key: 148528447
• Report Number: 3002808486-2019-00759
• 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: 08/26/2019

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: 11/14/2016
• Device Catalogue Number: IGTCFS-65-1-FEM-TULIP
• Device Lot Number: E3155320
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/29/2019
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 11/01/2013; 08/08/2019
• Supplement Dates FDA Received: 07/16/2019; 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 95