MAUDE Adverse Event Report: MEDTRONIC / MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR PIPELINE FLEX EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-325-16

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problems Stroke/CVA (1770); Emotional Changes (1831); Memory Loss/Impairment (1958); Ambulation Difficulties (2544); Convulsion/Seizure (4406); Speech Disorder (4415); Metal Related Pathology (4530)

Event Date 04/18/2021

Event Type  Injury  

Event Description

My wife has metal leaching into her brain.Dr.(b)(6) implanted a medtronic pipeline flex embolization device in her left paraclinoid.The device card ped-325-16 lot a654100 cartoid/cerebral coil/stent clip # 924-7267 surgical case # (b)(4) its platinum/tungsten and cobalt-chromium-nickel on (b)(6) 2021, (b)(6) received the stent with few issues.She was home in 24-hours and back to work in one week.On (b)(6) 2021 she could not coordinate her thumb and pinky.Mary was admitted to the bid emergency room 8:30am on may 19, 2021 she was diagnosed with a stroke.On (b)(6) at 6:40pm she had a 2 minute seizure, she woke up and did not know me at all, she did not know me as her husband she did not her children's names.(b)(6) was in neuro icu until (b)(6) 2021.She returned home and her hands were improving, but then she had another stoke on (b)(6) 2021 but dr.(b)(6) instructed us to wait home through the weekend.(b)(6) had a preplanned mri at 7:00am on (b)(6) 2021 then (b)(6) had another stroke on (b)(6) 2021 at 8:30pm and she was admitted to icu at (b)(6).On (b)(6) started the day alert but not talking well.By 11:00am (b)(6) could not talk, walk or communicate.Dr.(b)(6) called to tell me the (b)(6) 2021 mri was the worst he had ever read and mary needed immediate high dose steroids.Dr.(b)(6) gave (b)(6) a 50-50 to survive even though her vitals were normal.(b)(6) began high dose steroids 20 mg/day of dexamethasone and was transferred back to bid.On (b)(6) 2021 bid icu neurologist dr.(b)(6) told (b)(6) and i that the stent was leaching metal into (b)(6) brain, but because there are 7 materials in the stent they were not sure what may be leaching.On (b)(6) 2021 dr (b)(6) told us (b)(6) had metal leaching into her brain.On (b)(6) 2021 (b)(6) was discharged from icu to home.On (b)(6) 2021 during outpatient appt.With dr.(b)(6), dr.Became concerned about steroid psychosis as (b)(6) was worried about signing a disability insurance form in case her boss, the chief of vascular surgery at (b)(6) would find out about (b)(6) stroke.Dr.(b)(6) has been at (b)(6) bedside, he met with her while she was awake, while she was unconscious so dr.(b)(6) reduced (b)(6) steroids from 24 mg/day of dexamethasone to 18 mg/day, with a plan to tapper to 6 mg/day.On monday (b)(6) afternoon (b)(6) was certain i was going to institutionalize" her, but there as zero chance i would ever institutionalize (b)(6).On (b)(6) 2021 dr.(b)(6) told (b)(6) and i that he had never heard that the stent was leaching metal, and that we must have heard it was leaching metal from a "junior" nurse or "junior" resident who was wrong.He said he had never heard of any recalls involving the pipeline flex embolization device.(b)(6) and i found the medtronic paperwork for an fda recall of (b)(6) stent ped-325-xx.Between (b)(6) and (b)(6) became more and more psychotic and called the police at 3am on (b)(6) 2021 to falsely report that i was attacking while she was on the phone with 911.I have the video i took of her call to 911 as i was standing across the room terrified that she was breaking down, and in shock to hear my wife try to have me arrested as a way to stop me from putting her in an institution.The idea was never, ever discussed.I wanted (b)(6) home to recover.(b)(6) does not know me, and has struggled with every short -term memory task but also long term memories.She couldn't remember our wedding or wedding date on (b)(6) 2015 and she filed for divorce.Its (b)(6) 2021.I will attach mri pictures and some radiology images so you can see the leaching metal into her brain.I'll attach dr.(b)(6) white board drawing of the "cone of inflammation" at the exit end of the stent.Dr.(b)(6) said (b)(6) 2021 mri was the worst he saw in his career, so he sent the radiology materials around the usa and no one could confirm what was in the mri, except that it appeared to be a fatal condition unless treated.(b)(6) was a happy non aggressive person, she broke a door of the laundry area on (b)(6) 2021.Fda safety report id # (b)(4).

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC / MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
• MDR Report Key: 12106809
• MDR Text Key: 260035620
• Report Number: MW5102232
• Device Sequence Number: 1
• Product Code: OUT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PED-325-16
• Device Catalogue Number: 924-7267
• Device Lot Number: A654100
• 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; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 70