MAUDE Adverse Event Report: COOK MEDICAL GUNTHER TULUP IVC FILTER

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problems High Blood Pressure/ Hypertension (1908); Pneumonia (2011); Coma (2417)

Event Type  Injury  

Event Description

In (b)(6) 2009, i was admitted to (b)(6) hospital - (b)(6) with severe pneumonia.So severe i fell into a coma somehow within hours of admittance.Remained comatose for approx four weeks (after 2 weeks (b)(6) decided i, at (b)(6), healthy, weight appropriate, non-smoker was deemed needing a gunther tulip ivc filter.Cook medical authorization was supposedly obtained by my out of state mother.Bringing us to present day (b)(6) 2014, in a non-related admit to the very same hospital, (b)(6) lower bowel scan was performed for a blockage.I was informed by (b)(6) hospital.My ivc filter had fractured and migrated caudally towards my spine.What ivc filter and what are you (b)(6) speaking of denying.(b)(6) stated well who put this in you.I stated well this very hospital did.No discharge papers were given in 2009 on this procedure, no item number, no handy card that i learned i was supposed to have identifying this implant with mri and cat scan warning.No info at all.Especially that this was a temporary device, meant to be removed after need had surpassed.I don't believe it was ever needed in the first place.The hospital used me as a guinea pig with a device provided by cook medical and (b)(6) subsidies.Numerous contact with hospital to get medical records denied.Over and over i am told there is no record, this is a shelf item.I am denied healthcare all over.So in (b)(6) no doctor will see me due to this item and its affects.Months of attempts and still stonewall by (b)(6) hospital.To this date, i do not know the exact manufactures guidelines or warnings.

• Brand Name: GUNTHER TULUP IVC FILTER
• Type of Device: IVC FILTER
• Manufacturer (Section D): COOK MEDICAL
• MDR Report Key: 4724200
• MDR Text Key: 15344957
• Report Number: MW5042199
• 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: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Other Device ID Number: 00797299
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 72