MAUDE Adverse Event Report: UNKNOWN TITANIUM SURGICAL CLIP; CLIP, IMPLANTABLE

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Abdominal Distention (2601); Convulsion/Seizure (4406); Cough (4457); Wheezing (4463); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 04/28/2022

Event Type  Injury  

Event Description

I wanted to take a few moments to report my case in hopes that no one ever endures what i have had to since the removal of my gallbladder on (b)(6) 2022.I have several metal sensitivities and other allergies, and have for most of my life.When i presented to the er with a gallbladder full of stones, they said that it needed to come out very quickly because i was very sick.I was sent to a general surgeon who advised it would be coming out the next day.My pre-op visit lasted maybe 5 minutes.None of which included asking if i had a metal sensitivity or advising me that metal clips would be placed inside of me permanently.I had always associated my metal sensitivity with jewelry because i could not wear any form of jewelry aside from pure sterling, and even that caused mild irritation.On (b)(6) i was rushed into the hospital after experiencing the most intense pain i've ever felt in my life all throughout my chest and eventually stopped being able to breathe.My cystic duct had been swollen and blocked off completely with a stone and polyp in it.This is something important to note in hindsight because this is where my series of reactions started taking off.I was transferred to a regional hospital after my liver enzymes remained around the 1,000 mark and my other labs became elevated as well.I started having widespread itching at this time.They performed an ercp and i was released after about a week inpatient.My skin started crusting over, cracking and opening up initially on my hands, then my face, upper body etc.My family doctor assumed it to be eczema.On (b)(6) 2022, i suffered a grand mal seizure.I had never had a seizure before.I was again taken to the er.They could not find the cause of the seizure.My reactions had progressively gotten worse, i had trouble with wheezing, my hair was falling out, my abdomen was in intense amounts of pain and so swollen that people asked me when i was due, i was routinely out of breath and could not form sentences without gasping or coughing.I was put on steroids late may, prednisone 50mg, and sent to an allergist for testing.Remained on steroids.The allergist recommended stopping the steroids for 30 days and doing patch testing.Day 1 of no steroids landed me right back at my pcp's office because i was unable to breathe.My pcp sent me to a dermatologist for further evaluation noting that i could not stop steroids.I went to (b)(6) where (b)(6) took one look at me and saw blisters on my wrist where my apple watch sat and knew what was happening.I was having a systemic reaction to something.Upon evaluating my timeline, and history of metal sensitivity, it was determined that i was having a systemic reaction to the titanium clips placed inside of me at the time of my gallbladder removal.It seemed like an end to my misery, but my troubles had only just begun.No surgeons he contacted were willing to touch me.One group at (b)(6) in (b)(6) literally told me to get my affairs in order and be prepared because if my reactions continued to worsen, they could not help me.At 39, that hurt so bad to hear.I was hysterical.I could no longer get more than 2-3 words out before i could not breathe and that was while on steroids.I was told i could not stay on steroids any longer because my body had been impacted by long term use but i could not stop them because i would not make it.I started grasping at straws, talking to friends all over the country looking for resources.A friend then referred me to a dr (b)(6) in (b)(6) after presenting my case to him.This meant traveling to (b)(6) for surgery to remove the things that were killing me.He immediately came up with a plan and got those clips out without an issue by using a special dye to highlight the biliary tree to avoid injury and using a special tool for laparoscopic removal.On (b)(6), he removed 6 surgical clips including one that was free floating in my abdomen.

• Brand Name: TITANIUM SURGICAL CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16216058
• MDR Text Key: 307982969
• Report Number: MW5114416
• Device Sequence Number: 3
• Product Code: FZP
• 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: 01/17/2023
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: CALCIUM, VITAMIN D.; PANTOPRAZOLE 40MG, ZYRTEC 10MG, MONTELUKAST 10MG, TRAZODONE 25MG BEDTIME FOR SLEEP, PREDNISONE 10MG (TAPERING OFF), OXYCODONE 2.5MG (POST OP MED AS NEEDED).
• Patient Outcome(s): Required Intervention; Other; Life Threatening; Hospitalization
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White