MAUDE Adverse Event Report: COOK MEDICAL LLC COOK GUNTHER TULIP IVC FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

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

Patient Problems Pulmonary Embolism (1498); Stroke/CVA (1770); Paralysis (1997); Convulsion/Seizure (4406); Thrombosis/Thrombus (4440); Total Hearing Loss (4473)

Event Date 07/24/2014

Event Type  Injury  

Event Description

On (b)(6) 2010, i had a cook gunther tulip ivc filter placed at (b)(6).From 2011 to 2013 i had several pulmonary embolisms some which caused a small stroke, loss of hearing in my right ear.I also had seizures, and temporarily i had paralysis on my left side.On (b)(6) 2013, i had a surgery because clots were traveling in my body.I asked why this happened when i have a filter to prevent this from happening.In 2014 when i asked for the manufacturer and for medical device info, i was told there wasn't any documentation or labeling product id or the company and type of filter.On (b)(6) 2021 i received a voicemail from my primary doctor (b)(6) that the filter i had was a cook gunther tulip filter, but that there are no other records just the verbal one which i asked for it in writing and that was denied.According to the (b)(6) assured me that there aren't any recalls or documented with this type of ivc filter.I don't want anyone else suffering like i have, so i wanted to notify whoever about my complications and adverse side effects from the cook gunther tulip ivc filter.Fda safety report id#: (b)(4).

• Brand Name: COOK GUNTHER TULIP IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK MEDICAL LLC
• MDR Report Key: 11684915
• MDR Text Key: 246247756
• Report Number: MW5100828
• Device Sequence Number: 1
• Product Code: DTK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/24/2013
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 34 YR
• Patient Weight: 86