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

Catalog Number IGTCFS-65-JUG

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Atherosclerosis (1728); Myocardial Infarction (1969); Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

The previous mdr was submitted by (former manufacturer) under manufacturer report reference# 3002808486-2019-00165.Additional information provided determined that this device was manufactured by cook inc.With the submission of this initial report, cook inc.Informs that all future submissions regarding this complaint will be handled under this manufacturer report reference#.Additional information: occupation: non-healthcare professional.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

Patient allegedly received an implant on (b)(6) 2010 via the jugular vein due to intracranial hemorrhage and subsequently developed acute deep vein thrombosis (dvt).Patient alleges tilt, vena cava perforation, left lateral strut extending 5mm abutting right iliac artery, chest pain, abnormal ecgs, st-elevation myocardial infarction (stemi) requiring stent placement, moderate diffuse atherosclerotic disease of the tibial vessels, leg swelling/pain, leg discoloration.Patient further alleges to have experienced, "my left leg and ankle are severely swollen.".

Event Description

Per 18jan2019, ivc radiological report."a ct abdomen/pelvis study on (b)(6) 2016 identified the filter at the superior l3 to inferior l4 interspace.Migration was unable to be evaluated.No significant tilt was indicated (coronal 10 degrees to right).The imaging demonstrated a grade 3 perforation with a left lateral strut extending 5 mm abutting the right common iliac artery.".

Manufacturer Narrative

Additional information: investigation ¿ investigation reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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.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 chest pain, abnormal ecgs, st-elevation myocardial infarction (stemi) requiring stent placement, moderate diffuse atherosclerotic disease of the tibial vessels, leg swelling/pain, leg discoloration are directly related to the filter and unable to identify a corresponding failure mode at this point in time.The following allegations have been investigated: tilt, vc/organ perforation, chest pain, abnormal ecgs, st-elevation myocardial infarction (stemi) requiring stent placement, moderate diffuse atherosclerotic disease of the tibial vessel, leg swelling/pain, leg discoloration.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.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.

• Brand Name: GUNTHER TULIP JUGULAR 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: 8427761
• MDR Text Key: 139044211
• Report Number: 1820334-2019-00643
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K072240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2013
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: 2481181
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 88