MAUDE Adverse Event Report: STRYKER NEUROVASCULAR NEUROFORM ATLAS STENT SYSTEM; INTRACRANIAL NEUROVASCULAR STENT

Model Number REF # SZAS4521

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Aneurysm (1708); Headache (1880); Pain (1994); Reaction (2414)

Event Date 08/06/2018

Event Type  Injury  

Event Description

On (b)(6) 2018 i was brought to (b)(6) hosp in (b)(6) from (b)(6) hosp in (b)(6) via ambulance due to a suspected brain aneurysm.I had an angiogram on (b)(6) 2018 where dr (b)(6) discovered two brain aneurysms, one on the right ica and one on the left ica.The right ica aneurysm was leaking and that caused the headache which brought me to the hosp in the first place.They operated immediately on this aneurysm.When this surgery was completed, dr (b)(6) handed my husband the stent card and my husband noticed that the card mentioned that persons allergic to nickel may have "adverse reactions".I have a significant nickel allergy - i do not have pierced ears, i do not wear jewelry, etc.No one over consulted us about this device.My husband asked dr (b)(6) about this after he got the card and he said it wouldn't cause any problems.I was in the hosp for 4 days with extreme pain and migraines after surgery that were not managed.Add'l scars were completed to ensure that the stent was in the correct location.Ultimately they released me and assured me the pain would subside.I returned three weeks later for the second surgery on the left ica but the pain had not gone away.The left surgery was with a different device and went well.I had pain after surgery but it was managed after surgery with medication and subsided after a few weeks.It has almost been a year since the first surgery and i am still struggling with daily/chronic migraines, constant pain, and debilitating headaches.I have met with dr (b)(6) who assures me it was nothing he did- he told me to "drink more water and do yoga." i did not have this problem prior to surgery.Additionally i had a phone conversation with (b)(4), the medical dir of stryker, the company who made the stent on the right ica.He advised me that they have no info on persons with nickel allergies to share with me because they would have never placed this device in my body knowing i had a nickel allergy.Mr (b)(4) also let me know that the device had a humanitarian device exemption which means it did not go through normal clinical trials and that is why i couldn't find any info on it.The device was approved this way to help treat rare disorders affecting less than 8,000 people, but my aneurysms were not rare or difficult to treat.They were both in the largest vein of the brain, the ica, so it makes no sense why this device would have been used in the first place, let alone the fact that i have a nickel allergy.In the last year, i have tried 17 different medications to reduce my migraines and met with 6 different neurologists.My pain is currently not managed and i am still searching for answers as to why this is happening.Fda safety report id# (b)(4).

• Brand Name: NEUROFORM ATLAS STENT SYSTEM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): STRYKER NEUROVASCULAR
• MDR Report Key: 8826302
• MDR Text Key: 152523696
• Report Number: MW5088357
• Device Sequence Number: 1
• Product Code: NJE
• 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: 07/23/2019

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: No Information
• Device Model Number: REF # SZAS4521
• Device Lot Number: 20423708
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 30 YR
• Patient Weight: 86