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

Model Number G33016

Device Problem Structural Problem (2506)

Patient Problems Perforation of Vessels (2135); Anxiety (2328); Depression (2361)

Event Type  Injury  

Manufacturer Narrative

The previous medwatch report was submitted by william cook europe under manufacturer report reference# 3002808486-2022-01006.Additional information provided determined that this device was manufactured by cook inc.With the submission of this initial medwatch report, cook inc.Informs that all future submissions regarding this complaint will be handled under the manufacturer report reference # referenced in this initial medwatch report.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.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 (vc) perforation, stress, depression, anxiety.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This 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: vascular trauma, vena cava perforation, vena cava penetration.Unknown if the reported stress, depression, and anxiety are directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of 20 devices were manufactured in the reported lot.To date, one other complaint has been reported against the lot 2858872.The associated work order was reviewed.No related/relevant notes were documented.The device 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 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) 2011 via the right common femoral vein due to acl implanted surgery preparation.Patient is alleging vena cava perforation, and filter abuts duodenum.Patient alleges "stress, anxiety." depression.Per computed tomography (ct) report, "the inferior vena cava filter appropriately positioned below the renal veins.There is no evidence of filter migration:.The inferior vena cava remains patent.The anterior, posterior, medial and lateral portions of the filter appear to protrude beyond the lumen of the inferior vena cava.The anterior portion of the filter abuts the posterior margin of the duodenum.There is no filter erosion into the aorta.".

• Brand Name: GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15924350
• MDR Text Key: 304894554
• Report Number: 1820334-2022-01811
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002330167
• UDI-Public: (01)10827002330167(17)141001(10)2858872
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2014
• Device Model Number: G33016
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 2858872
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Female
• Patient Weight: 66 KG