MAUDE Adverse Event Report: COOK MEDICAL GUNTHER TULIP IVC RETRIEVABLE IVC FILTER FEMORAL DEPLOYMENT

Model Number G03766

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problem Pain (1994)

Event Date 05/05/2015

Event Type  Injury  

Event Description

Gunther tulip ivc filter cook medical implanted while comatose at (b)(6) on (b)(6) 2009 for unk reasons other than pneumonia, unreported until undiscovered (b)(6) 2014 in unrelated procedure at same hospital (b)(6), now 5+ years of dwell time.No surgeon would treat to initiate are due to litigation with this device.I carried it like an alien (b)(6), in-spite authorized order for care every referral was declined all over (b)(6).I was as much as told by my insurance company go to hospital of choice an flop on the floor in pain treatment then obligated by facility.I switched health groups to (b)(6).Enter doctor (b)(6).Immediately i noted an attitude towards me and my prognosis and attributing multiple symptoms, severe lower back pain, leg spasms and weight gain.Always healthy other than 2009 incident (b)(6) always worked in active careers, went to (b)(6) safari post 2009 hospitalization.I know my body very well and something was majorly wrong.Every visit was followed by a summary report of dr.(b)(6)."in my professional opinion the pts multiple symptoms are not related to the implanted device.Never referring to it as what is was a gunther tulip cook medical retrievable ivc filter femoral deployment (b)(6) 2009.No sense of urgency in spite of noted findings on health risks ever increasing on these devices.I was told "well the retrievable filter where also intended for permanent placement." a story that would ultimately change to dr.(b)(6) statement of good thing you got that removed when you did (b)(6) 2015 at (b)(6), increasingly i got upset at the condescending attitude and false statements by my surgeon.I brought in numerous printouts of symptoms and dangers of these ivc filters specifically the retrievable types.I was deemed as paranoid quote "in spite of pt being warned of eminent hemorrhage and high risk of death", it is pts wishes to proceed with surgery.All summary reports where redacted void of ct scans urgent findings stated by radiologist hepatic changes in liver advise f/u, filter migrated and tilted, struts separated and speared into l3 lombard (but my back pain and symptoms not attributed to the denigrating device in me.) the extraction surgery was a horror movie, pieces embedded in layers of my liver and deep within stomach and uterine wall, the actual cava and vein to be wrapped suspended with umbilical tape dissected set aside in layers were lysed so wire cutters could cut out broken filter legs.Surgical manifestation was pronounced a complete success with no complications.A 12" x 1/4" gashed scar across abdomen was not noted.No aftercare was given, no venography, vena gram, or ultra sound was given pre or post op for comparisons.Waker now than pneumonia onset in 2009.A multitude of g.P.Visits over months symptoms to severe pain in odd places.A year in bed, a major surgery this may be what it takes.Tried to get back to my life, shortness of breath increasing to no more than 5 steps, heart palpitations and leg swelling on my.On my own request, dr.(b)(6) for an urgent f/u, ct scan, amazingly performed same week.Again dr.(b)(6) states "pts symptoms this far out from surgery are in my opinion not related to the placement or removal of the device." tired of bulltrain i was on.I obtained all my medical records, hepatic liver changes greater than radiologists f/u advised.Tilt in uterine position, renal cysts, liver nodules, attenuation, f/u advised.Never inform my gp, no chance preemptive care.Anteroseptal myocardial infarction (b)(6) 2015 day of surgery redacted not informed.Now (b)(6) 2017 hospitalized liver failure venacava syndrome, matched ecg anteroseptal myocardial infarction, a death sentence, possibly avoided if dr.(b)(6) not compensated trials product recipient of cook medical inc., maker gunther tulip ivc filter.

• Brand Name: GUNTHER TULIP IVC RETRIEVABLE IVC FILTER FEMORAL DEPLOYMENT
• Type of Device: GUNTHER TULIP IVC RETRIEVABLE IVC FILTER FEMORAL DEPLOYMENT
• Manufacturer (Section D): COOK MEDICAL ; bloomington IN
• MDR Report Key: 6405749
• MDR Text Key: 70099912
• Report Number: MW5068447
• 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: 03/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2009
• Device Model Number: G03766
• Device Catalogue Number: IGTCFS-65-8.5-1-FEM-TULIP
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: APPLE CIDER VINEGAR ULFILTERED; L-LYSINE; MILK THISTIE; RX MEDS: SPIRONOLACTONE 25 MG; STEROID CREME; TYLENOL CODEINE; VITAMIN B12; VITAMIN D
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 80