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Lot Number
Device Problems Material Erosion (1214); Material Protrusion/Extrusion (2979)
Patient Problems Pain (1994); Burning Sensation (2146)
Event Date 11/27/2017
Event Type  Injury  
Event Description

In (b)(6) 2008 i became sick and required hospitalization. While hospitalized i developed a blood clot in my upper right groin area of right leg. My drs decided a cr bard g2 permanent ivc filter needed to be implanted in my vena cava vein to catch blood clot if it moved. I was sedated and radiologist implanted the ivc filter. (last time i thought about filter was when it was implanted as it required no care from me). On (b)(6) 2017 as i was walking down stairs in my home a "burning pain shot through my upper groin around my back and into abdomen" this pain "blent me over double" and took my breath away. I could not move i held on to stair railing as i thought i was going to pass out. The pain lasted about 4-5 mins and left as suddenly as it came. I stood up and felt no pain so i continued down stairs. The pain continued off and on the entire (b)(6) weekend. On monday after (b)(6) i've seen my primary care physician and he wrote the pain off as a pulled muscle in my lower back and prescribed muscle relaxers for a few days. The pain once again disappeared as quickly as it came and for days i had no pain. Then out of the blue while shopping for christmas it hits me again. It truly "debilitating" when it hits me. So once again i see my pcp whom sends me to an orthopedic physician. He does some x-rays and points out to me that i have an ivc filter implanted in my vena cava vein. I had forgot all about filter as when his nurse asked me if i had any implants before doing x-rays i stated no. The orthopedic physician said i needed six weeks of physical therapy to work soreness out of back muscles. I did not agree with his treatment plan but completed the six weeks of physical therapy hoping it work. (during the weeks of pt the pain was intermittent but the severity of pain was always breath taking. I was back and forth with pcp looking for answers to this unexplainable pain. My anxiety level was pushing me over the edge as i feared this pain coming and going every second of every day. Fast forward (b)(6) 2020, my pcp after i was ready to shoot myself ordered a ct of my abdomen and pelvic. In this ct is shows the following: one ivc filter in my vena cava vein. It is tilted embedded and the several of the struts had protruded through the ivc wall; 02 of the struts were eroded and protruding to the location of my "ilioinguinal or illiohypogastric" nerves. This is what was causing the horrible unexplainable pain i had felt and dealt with both physically, and mentally for 3 years. There was other eroded struts that had protruded through the ivc wall with one of the struts entering my penetrating my abdomen causing a "2 cm aortic abdominal aneurysm". My pcp sent me immediately to a vascular surgeon whom studied the disk of my ct scans and his opinion was and i am quoting him from his report "given that attempted removal either endovascularly or with an open operation the high risk of bleeding would be uncontrollable and the risk of catastrophic complications of tearing the inferior vena cava. Pt also has a bleeding and clotting disorder which would require transfusions. The pt is at a high risk of migration of eroding arms and legs of ivc filter due to age of what was suppose to be a "permanent filter". You can not image how this ct scan and consulting report from vascular surgeon has turned my world upside down. Now i am dealing with an aortic aneurysm in my abdomen, terrible, debilitating pain in my groin back and abdomen and am at high risk for deteriorated broken ivc filter to migrate to other life threatening parts of my body. I live 80 miles from the closest hosp that could take care of a ruptured aortic aneurysm. That's really sad as usually you have about 2 mins when one ruptures before death. How could this happen? i am only (b)(6) y/o, i retired a couple of years ago from 28 years as a licensed (b)(6) nursing home administrator and spent years in healthcare finance, (b)(6). I am heart sick that a medical device company would continue to market their cr bard g2 ivc filters when told by their own healthcare medical consultants that these filters were not safe for implant due to high rate of breakage and migration and "definitely" needed more research completed on them. Cr bard thought more of their stock prices staying steady than they did the lives of innocent pts who trusted them to build and manufacture an ivc filter that would help to save lives when needed. Both drs and hosps were mislead about the cr bard g2 filter as there was no warning as to the high rate of breakage to the device and filter migration that would cause pt grave outcome and possible death. Look back over cr bard's record of faulty medical devices they have built through out of the years and been fined for in court for not following fda procedures. Cr bard has taken my vitality away. As i am now scared to death to move because of the possibility of g2 ivc filter braking apart and migrating or aortic aneurysm rupturing. My family is devastated my heart is crushed. I have 7 beautiful grandchildren i want to see grow up. I am just broken hearted. Fda safety report id# (b)(4).

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Manufacturer (Section D)
MDR Report Key9805109
MDR Text Key183264446
Report NumberMW5093602
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 03/04/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device LOT Number
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Date Received: 03/06/2020 Patient Sequence Number: 1