• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LUNG-VICRBRACHY TYL MESH SUTURE INTERSTITIAL IODINE I-125 IMPLANT; BRACHY THERAPY LUNG-VICRYL MESH SUTURE INTERSTITIAL IODINE I-125 IMPLANT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LUNG-VICRBRACHY TYL MESH SUTURE INTERSTITIAL IODINE I-125 IMPLANT; BRACHY THERAPY LUNG-VICRYL MESH SUTURE INTERSTITIAL IODINE I-125 IMPLANT Back to Search Results
Device Problems Material Disintegration (1177); Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Fistula (1862); Hemorrhage/Bleeding (1888); Pain (1994); Pneumonia (2011); Tissue Damage (2104); Weakness (2145); Discomfort (2330); Impaired Healing (2378); Respiratory Tract Infection (2420); Respiratory Failure (2484); Ambulation Difficulties (2544); Lethargy (2560); Hypervolemia (2664); No Code Available (3191)
Event Date 06/01/2004
Event Type  Injury  
Event Description
On (b)(6) 2013, respiratory failure.(b)(6) fought through and survived lung and brain cancer for 5 years.And also another several years of being sick, testing and suffering trying to find out why she was having so much pain and discomfort and illnesses after all of that only to find out that a medical mistake on the doctors and hospital staff's part to cover-up movement of the implant and condition of it.It still possibly could kill her anyway.Ultimately after years of suffering at the hands of all these drs hiding their mistakes and from what we see hospital and dr cover ups.(b)(6) once again ended up in the hospital admitted for pneumonia to (b)(6) hospital here in (b)(6) then on (b)(6) 2013, she started coughing and coughed up a huge amount of blood and pus and a blood clot or a pleural fistula? or cyst? she went into respiratory failure was put on a ventilator and kept in a coma while on the ventilator.Dr.(b)(6) was avoiding me so the nurse from i.C.U.Said she would help me catch up with him on that saturday afternoon, i left while i was gone dr.(b)(6) came in stated that he was leaving and going on vacation and (b)(6) would have to stay on vent.Until dr.(b)(6) could make it in to see her on wednesday (4 days later)? at that point the nurse called me and told me to get back there and get a hold of dr.(b)(6) before he left for vacation or no-one could do anything for (b)(6) until dr.(b)(6) came in on wednesday.So immediately i went back to the hospital as soon as i went through the i.C.U.Doors dr.(b)(6) jumped up and stated it was not me it was the surgeon that left that suture in her lung, it was the surgeon who did this! and he immediately got all defensive with me and so i told him to get dr.(b)(6) on the phone, dr.(b)(6) then stated he could not leave (b)(6) until wednesday to see her, but if he wanted to transport me down there to him by ambulance because the weather was too bad to fly her down there.Then dr.(b)(6) said no she is too critical to transport there, so i had to have the nurse call dr.(b)(6) to get the orders to transfer her and all her records to dr.(b)(6).So when the ambulance driver came in to transport her and said "geese i am a paramedic not a record keeper" so he went and got a dolly to carry her and all her records to (b)(6) hospital.I met with dr.(b)(6) outside of i.C.U.Around 1:30 or 2 am.He then stated that he would have to go in and do surgery and see for himself what caused the respiratory failure and address the bleeding and suture or whatever caused the cyst or fistula? so he and the i.C.U.Nurse stated to stay around because i would have to sign some authorization forms before surgery.I waited outside the i.C.U.Doors all night neither of them ever came? finally, around 8am i demanded to see my wife, the nurse said she was in recovery the dr.Did the surgery but he left? i then said that he left without my signature or even talking to me about results, the surgery or anything? so we, me, and my sister-in-law waited all day sunday for the dr.Or results or anything and he never returned.Then on monday morning, some people i am assuming attorneys or administration working for the hospital came into the i.C.U.Unit and passed out some papers (gag orders?) to all of the staff in the i.C.U.Working with (b)(6).At that point the nurses said they were not allowed to talk to us about anything but release forms and they had never seen anything like this, but they were so sorry.Two hours later, they came in and said that they might send (b)(6) upstairs for recovery then before i knew it they came back and said they were discharging her to home, and told me to follow up with the p.Cp.And if i had questions to follow up at home or if any serious problems, go to e.R.So they discharged her to home with no step down from critical care.And was very weak and when i brought her home i had to carry her in the bathroom because she was so weak and her feet and whole body was so swelled she could not walk on her own.Never did get to see or talk to dr.(b)(6) before discharge from (b)(6).The next day we went to see dr.(b)(6), he then ordered her lasix, lmodium and complete bed rest also a fluid restriction until he could speak with dr.(b)(6) or dr.(b)(6).We then left and headed home, and she started coughing up a huge amount of blood so i called dr.(b)(6) back, he said take her directly to hospital for admission.Then she was admitted to (b)(6) for another 28 days for coughing up blood, fluid overload and c-diff and infection in the lungs and airway.Dr.(b)(6) was in i.C.U.Waiting for me and handed me a surgery report that stated the suture was in there from her original surgery in 2004? in the meantime, i kept trying to get a hold of dr.(b)(6) for 2-3 months to figure out what was her best course of care, he would not return our calls so while trying to get a hold of him, we went several other surgeons for a second opinion and of course they all told us to go back to dr.(b)(6).So i then had to get an attorney to send him a letter.He then called us back and set up an appointment for surgery said she would need surgery.After 2 surgeries, he then said she would need 12 or 13 more surgeries 3-4 months apart to straighten her airway and dilatation laser and lavage to remove the remainder of the suture material in her airway and lung, but then he said he was leaving to move out of town, so he was leaving me in the care of dr.(b)(6) and he would do the remainder of the surgery after 2 or 3 surgeries with much difficulty, he then referred us to his boss at (b)(6) center dr.(b)(6).Also during all of these surgeries (b)(6) started coughing up staple's, radiation seeds and mesh material and off and on blood we were just told go to e.R., if she coughed up more than a teaspoon of bright red blood, we then went to see dr.(b)(6), he ordered a 3d scan of the area and when we went back to see him he then informed us that the mesh implant that was installed in the original surgery had moved down over the airway and has just laid there and damaged her airway.She would not be a candidate for a lobectomy or a lung transplant.But, he would continue dr.(b)(6).We then said that was great as long as he would do the surgery because at this point we were not willing to be treated by anyone not familiar or unqualified to treat (b)(6) and this situation she was in.He agreed and stated he would do them himself.Then it seemed hospital administration found out he was treating (b)(6).And according to my paperwork he only actually did 1 or 2 procedures himself.So over the course of 7 or 8 procedures he only did 1 or 2 and let newly graduated drs or student drs do the remainder of all the other procedures and let on to us that he was doing those procedures.See before or after any procedure they would either come in with people with no name tags or people in suits, and when we asked to see him we had to go to where ever he was at presbyterian or montefiore hospital other than that they would schedule her to see a physician's assistant and would always schedule us end of the day, and we would wait hours to talk to somebody.None of the drs would even acknowledge that (b)(6) implant was falling apart until (b)(6) started coughing up seeds and staples etc.So in closing i don't think my wife should have had to fight and beat cancer twice, and then 10 years later die and be resuscitated to get even half of the truth as to what is even going on with her health care and for anyone to even acknowledge the fact that this implant is eroding and coming out through her airway when it was supposed to be there for life to reinforce her lung.And because she is now in this predicament she may have to have these procedures for the rest of her life well how much of her life she may have left? because too, two corporate entities were trying to merge and neither one wants to address the real issues here.Thank you for your time and consideration in this matter.Any questions please call 724-658-8237 or 724-657-7554.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LUNG-VICRBRACHY TYL MESH SUTURE INTERSTITIAL IODINE I-125 IMPLANT
Type of Device
BRACHY THERAPY LUNG-VICRYL MESH SUTURE INTERSTITIAL IODINE I-125 IMPLANT
MDR Report Key5431279
MDR Text Key38132200
Report NumberMW5060131
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 02/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/09/2016
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Age36 YR
Patient Weight59
-
-