MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.5 X 21MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003SZAS45210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Hypersensitivity/Allergic reaction (1907)
Date of Event	06/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.However, allergic reaction and neurological/intracranial sequelae like headache are known risks associated with endovascular procedures and are noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications has been assigned to this event.Subject device remains implanted.
Event or Problem Description
It was reported that following successful stent-assisted coil embolization with the subject stent, the patient complaints of severe headaches since the device was implanted.The patient is inquiring about nickel allergy since the patient is allergic to nickel.According to the physician, the allergy and headaches were not related to the subject stent device.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 4.5 X 21MM WITHOUT TIP
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8232687
• Report Number: 3008881809-2019-00014
• Device Sequence Number: 19070022
• Product Code: NJE
• UDI-Device Identifier: 07613252656210
• UDI-Public: 07613252656210
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: H020002/S046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2023
• Device Catalogue Number: M003SZAS45210
• Device Lot Number: 20423708
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5 TARGET COILS (STRYKER)
• Outcome Attributed to Adverse Event: Other