MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP., MARINA BAY CUST. FULFILLMENT CENTER BOSTON SCIENTIFIC INTERLOCK DETACHABLE EMBOLIZATION COILS; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Device Problem Break (1069)

Patient Problems Diarrhea (1811); Fatigue (1849); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Ischemia (1942); Itching Sensation (1943); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Malaise (2359); Numbness (2415); Sleep Dysfunction (2517); Cognitive Changes (2551); Cough (4457); Angioedema (4536)

Event Date 09/11/2020

Event Type  Injury  

Event Description

Boston scientific interlock detachable coils were inserted into a splenic artery aneurysm (saa) on (b)(6) 2020.I felt okay in recovery, but when the nurse got me up to ambulate, i had a sudden sharp pain in the right upper quadrant of my abdomen (spleen area).This pain was an 8/10 and lasted for several weeks.On 14/sep/2020, a follow up scan indicated a splenic infarct.I was hospitalized from 16 sep to 18 sep for pain management.Since the procedure on (b)(6) 2020, i have developed the following symptoms and am very concerned about a hypersensitivity reaction to one or more of the metals in the coils: hair loss (have to clean out brush every few days instead of weekly, shower drain after each shower).I can do my pony tail holder 6 times instead of 5.Hair feels thinner; extreme fatigue (like sleeping 13+ hours at a time, taking naps).This is worse than after my thyroidectomy.I have a hard time staying awake; brain fog: missing stuff at work that i didn't before and difficulty focusing.One night i was driving home and i almost stopped at a green light.I have found that i forget words and have to really focus to find the word i am looking for; numbness in bilateral ring and pinky fingers; increase in mucus/drainage.Started about the same time as the hives, mucus is clear but is constant in nose and throat.Intermittent cough that sounds way worse than it is; general malaise.I know my body has been through a lot over the past 4 months but i just don't feel well overall and i know when something is not right; continued spleen pain and pressure.Always feels like something is there.Worsens when lying down or after eating; intermittent diarrhea.No gi symptoms like pain or grumbling or sudden urge to go or anything like that; constant itching/hives somewhere on my body.Groups of hives will just spring up, itch like crazy, and then go away in 1-2 hours.No correlation to food or medication or temperature; angioedema in my hands, feet, lips, tongue, eyes.It will be random and comes on suddenly.I've gotten sore spots on my tongue from it pressing against my teeth.No correlation that i have made with food or medication; daily headaches my primary care physician has run many tests to see if there could be any other explanation.All of my labs have been normal.The only lab blood test that i have found that tests for platinum and tungsten hypersensitivity is through melisa which is very costly and requires me to send my blood to germany.I also wanted to make sure that someone had reported to you that one of the coils broke during my procedure.I was awake throughout the entire procedure and i heard the interventional radiologist say, "great.One of the coils just broke." my procedure was done by interventional radiologist dr.(b)(6) at (b)(6) medical center.(b)(6).Fda safety report id # (b)(4).

• Brand Name: BOSTON SCIENTIFIC INTERLOCK DETACHABLE EMBOLIZATION COILS
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP., MARINA BAY CUST. FULFILLMENT CENTER
• MDR Report Key: 11286116
• MDR Text Key: 230754579
• Report Number: MW5099252
• Device Sequence Number: 1
• Product Code: KRD
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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
• Patient Age: 43 YR