MAUDE Adverse Event Report: COOK MEDICAL / WILLIAM COOK EUROPE APS GUNTHER TULIP IVC FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number DENMARK EUROPE

Device Problems Partial Blockage (1065); Entrapment of Device (1212); Fracture (1260)

Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); Swelling (2091); Tricuspid Regurgitation (2112); Depression (2361); Ascites (2596); No Code Available (3191)

Event Date 05/11/2017

Event Type  Injury  

Event Description

On (b)(6) 2015 extraction of broken gunther tulip ivc filter.Cook medical in a constant effort of surgeon to protect causation of cook medical's fractured, embedded and ivc occluded filter, (b)(6) keck hosp vascular team a huge recipient of cook incorporated fundings, trials and product review.Pt records redacted, missing and denied, putting the pieces together with blank pages of e.O.B.Summarized as a complete success pt developed severe pulmonary hypertension idiopathic, severe morbid right heart pressure.Denied further rare by (b)(6) when problems began to arise, questioning missing and falsified records.I am told the purple swelling ankles, ascites, loss of ability to function in what otherwise was a healthy (b)(6) female.I am seeing i have become the perfect storm silenced to watch my death unfold.Protamine, glycopyrrolate, neostigmine, my ivc reconstructed any method, no post op f/u, no anticoagulent prescribed though noted after the fact i was never instructed by as much as an aspirin.Records were failed not to be forwarded to p.C.P.If same (b)(6) care medical group.More complications arose, i was labeled with depression.Sertraline, gabapentin, xanax and bupropion were all prescribed at same time, and when i questioned why so many pills, what is the cause of the symptoms, was given an increase in sertraline dosage.End result 2 years post op: severe pulmonary hypertension, severe right heart over load pressure, tricuspid regurgitation, miserable painful morbid outcome.I strongly believe this did not and should not have occurred.All were so intent in protecting a pharmaceutical money pit.Cook medical all industry standards were fully ignored; 998.4 foreign body accidentally be left in pt, failure vascular device, reconstruction of my ivc with my femoral vein all required cause for care during f/u care.Care for the pt not proceeding only to appease ongoing litigations.Time after time requests were not just denied but ignored all together so statute of limitations prevails.Not one adverse effect was reported by (b)(6) and my extraction with complications was coded.Elective procedure patients wishes.I have all test results and missing and redacted medical records.Does anyone realize this is occurring.Not just the morbid outcome to me but now i have 100,000,000 of thousands of medical costs the system is having to spend to try and keep me alive as (b)(6) and cook medical operate as non profit tax exempt to the system.Fda safety report id# (b)(4).

• Brand Name: GUNTHER TULIP IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK MEDICAL / WILLIAM COOK EUROPE APS
• MDR Report Key: 8612935
• MDR Text Key: 145482587
• Report Number: MW5086663
• 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: 05/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DENMARK EUROPE
• 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; Disability
• Patient Age: 52 YR
• Patient Weight: 72