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

Model Number 1GTCFS-65-1

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

Patient Problems High Blood Pressure/ Hypertension (1908); Nausea (1970); Nerve Damage (1979); Pain (1994); Swelling (2091); Abdominal Distention (2601); Device Embedded In Tissue or Plaque (3165)

Event Date 05/26/2015

Event Type  Injury  

Event Description

Deployed in 2009, i was informed that these filters are meant to be retrievable as well as permanent many (b)(6) informed me, physicians cautioned to take removal on the gunther tulip fern ivc filter was discovered 2014 to have fractured, embedded the caval wall, posterior leg calcified in l2 lombard body to follow my treating (b)(6) order of removal defective device.Vascular surgeon keck medicine of usc took on complex open retrieval with no attempts possible with the retrieval kit.A 13 inch abdominal incision, my entire abdominal contents laid out of me thee various spikes and legs were lyssed, dug, and various forms of spreading me open through the psoas and reconstructing the vena cava with interruption of blood flow and a back bleed of various parts of my inflicted organs.I had one follow up.One.Physician documents successful retrieval patient symptom free.No other follow up was offered or given.A year in bed each time i tried to resume my life severe back pain, general weakness, my g.P.Diagnosed as depression.And let's not blame it on the operation.On my own i contacted the surgeon who promptly got me in for a c.T.Scan.To find liver attenuations, renal cysts, renal lesions, ovarian cyst, thickening of uterine wall and numerous artery clips my surgeon had not disclosed to me they were used and left in me.Again the surgeon calls it "in his professional opinion symptoms not related to the device or its retrieval" the continuing severe lower back pain shooting down my legs, major increase in blood pressure, weakness and distended abdomen are sited as menopause.I am sent on my way.From bad to morbidly bad, symptoms persist, i swell up nearly twice my size.With my surgeon reporting retrieval a complete success the emergency room doctors are of opinion i am false in my stating this is from removal of ivc filter.My body was shutting down.New health provider is obtained to diagnose ipah pulmonary hypertension, i am told it is from interruption of blood pathways and damage to vena cava.I am told the damage is irreversible, the condition non-curable, progressive and i am 2 years into a 3 to 5 year survival.Present day.Legs and ankles purple and scaling swollen, back in pain never ending, nausea and inability at this point to care for myself.I was very young and healthy for my age.A person has a very slim chance once complications occur and when your surgeon is a compensated spokesperson for the same company that produces said device.Well they hope you quietly go away.I am on that path.

• Brand Name: GUNTHER TULIP RETRIEVABLE IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK MEDICAL LLC DENMARK/IND; DA
• MDR Report Key: 7295811
• MDR Text Key: 101113885
• Report Number: MW5075489
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• 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: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1GTCFS-65-1
• Device Catalogue Number: FEM TULIP 30 50
• 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; Other; Required Intervention; Disability
• Patient Weight: 76