MAUDE Adverse Event Report: COOK, INC. GUNTHER TULIP RETRIEVABLE IVC FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number IGTCFS-65-1-FEM-TULIP

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/26/2015

Event Type  Injury  

Event Description

Gunther tulip ivc filter cook medical, (b)(4) deployed 2009 while comatose, pt recovered completely, to then discover (b)(6) 2014 of same treating hosp, informed a gunther tulip ivc filter was present unbeknownst to me, (b)(6)/ pt.Filter now embedded, migrating, fractured, lodged in l2 lombard vertebral body, ordered defective device for immediate removal risk of embolism.Referred to (b)(6) who files to act on order of removal stating more tests are needed and mfr recommends temporary filters are feasible for permanent use, 6 months of continuous tests, are performed and charged to health care provider.Findings of recommendation for concern and f/u denied and ignored.Open extraction exploratory laparotomy to dig through pt's body to remove piecemeal filter and parts embedded in organs and body structure; 13 inch scar across abdomen; pt summary of operative procedure in no way matches detailed billing ledger; "7 various defective failed vascular devices are used to mask the operative code (b)(6) removal of fractured ivc filter." (b)(6) fiduciary bond with cook incorporated prevented life saving care and pre-emptive diagnosis.Operation labeled "elective procedure," pt's wishes.Artery clips used against pt advance directives "do not put anything in my body not of my body".Re-routing of venous pathways 2.5 years of morbid health complications new provider diagnosis.Severe rt aortic pressure, tricuspid valve regurgitation, pre-preventable or at worst if caught early maintainable, active healthy (b)(6) y/o female now has to grieve her own death and live it.No 803 was filed to mfr by (b)(6).No repercussion to (b)(6) in failure to treat, diagnose or report.No report on file with cook medical, cook incorporated.(b)(6) physician, free to testify in any litigation.In his professional opinion, pt's symptoms are not related to the filter.That sentence is the only cause of action given as it is present in every summary report of dr (b)(6).On (b)(6)2014 ct abdomen and pelvis reason stated > fvc filter l3 filter legs demonstrate caval penetration, posterior leg is fractured and penetrating into large l2 vertebral body osteophyte or heterotopic ossification, pleural mass 23 x 55 cm.Uterine fibroid - (b)(6) 2014 abdomen and chest ct reason stated retained foreign body to evaluate pleural mass and opacity of lungs deemed scar tissue and not related to post ivc filter removal; (b)(6) 2016 ct abdomen and pelvis - left hepatic lobe attenuation, liver nodules, renal cysts, ovarian cyst, thickening of uterine wall.Recommendation for f/u denied.Dr (b)(6) states menopause symptoms, in his professional opinion not related to ivc filter; 4.5 months later, (b)(6) hosp emergency room, severe rt aortic pressure.Partially dilated vena cava tricuspid valve regurgitation, liver nodules cirrhosis, ruled out as false read of renal failure.No diagnosis or cause is given as (b)(6) reports operation, a complete success, no complications.Diuretics are prescribed and pt discharged with no heal provider, and seeking new health provider.

• Brand Name: GUNTHER TULIP RETRIEVABLE IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK, INC.
• MDR Report Key: 7739190
• MDR Text Key: 115890487
• Report Number: MW5078747
• 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: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IGTCFS-65-1-FEM-TULIP
• Device Catalogue Number: G52917
• 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 Age: 52 YR
• Patient Weight: 71