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

Catalog Number IGTCFS-65-FEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Aneurysm (1708); Thrombosis (2100); Dizziness (2194)

Event Type  malfunction  

Manufacturer Narrative

The previous mdr was submitted by william cook europe under manufacturer report reference# 3002808486-2018-00756.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#.

Event Description

Patient allegedly received an implant on (b)(6) 2016 due to recurrent deep vein thrombosis in both legs.Patient alleges abdominal aneurysm, filter in place more than 90 days without further details.Patient further alleges dizziness, vertigo, post implant deep vein thrombosis, fear.It is alleged that "[pt] received a gunther tulip filter on (b)(6) 2016 at (b)(6) medical center; (b)(6) by implanting physician (b)(6).".

Manufacturer Narrative

Additional information: investigation ¿ investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Unknown if the reported abdominal aneurysm, filter in place more than 90 days, dizziness, vertigo, dvt, and fear are directly related to the filter and unable to identify a corresponding failure mode at this time.The following allegations have been investigated: abdominal aneurysm, filter in place more than 90 days, dizziness, vertigo, dvt, fear.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 provided at this time.

• Brand Name: GUNTHER TULIP FEMORAL 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: 8423276
• MDR Text Key: 139057786
• Report Number: 1820334-2019-00635
• 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
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 111