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

Catalog Number IGTCFS-65-FEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Thrombosis (2100); Transient Ischemic Attack (2109)

Event Type  Injury  

Manufacturer Narrative

The previous mdr was submitted by wce under manufacturer report reference number 3002808486-2018-00657.Additional information provided determined that this device was manufactured by cinc.With the submission of this initial report, cinc informs that all future submissions regarding this complaint will be handled under manufacturer report number referenced of this initial medwatch report.Occupation: non-healthcare professional.Investigation: investigation is reopened due to additional information provided.Unknown if the reported pain is directly related to the filter.Unknown if the reported stroke, tia, and blood clots in legs are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.No relevant notes on work order.No other complaints on lot.Product is manufactured and inspected according to current controls.This report includes information known at this time.A follow up report will be submitted should additional information become available.

Event Description

Pt allegedly received an implant on (b)(6) 2010 via the right common femoral vein due to deep vein thrombosis.Pt is alleging stroke (2015), blood clots in both legs in (2017), and mini stroke (tia) (2017).Pt further alleges "attendant pain and suffering.".

• 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
• 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: 9516343
• MDR Text Key: 184118890
• Report Number: 1820334-2019-03162
• Device Sequence Number: 1
• Product Code: DTK
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2019

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: 06/01/2013
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 2531133
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2010
• 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 Weight: 95