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

Catalog Number IGTCFS-65-JUG

Device Problems Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

William cook (b)(4) initially reported event under manufacturer report #3002808486-2017-02536.New information was received identifying that the product was a cook inc.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

Pt allegedly received an implant on (b)(6) 2010 via the right internal jugular vein due to pulmonary embolism, vein thrombosis.Pt is alleging tilt, vena cava perforation, perforation in the mesentery, bleeding in the lungs, shortness of breath and fatigue.The patient further alleges anxiety and stress.

Manufacturer Narrative

Additional information investigation - it has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'gunther - tilt, vc & organ perf, bleeding in lungs, shortness of breath, fatigue, anxiety, stress - updated sfc.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.Unknown if the reported bleeding in lungs, shortness of breath, fatigue, anxiety, stress is directly related to the filter and unable to identify corresponding failure mode(s) at this 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.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.H3 other text : 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: 7308237
• MDR Text Key: 101341989
• Report Number: 1820334-2018-00618
• 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: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-JUG
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 118