MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003SZAS30210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Headache (1880)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the first of 3 reports.Subject device remains implanted.
Event or Problem Description
The patient underwent successful stent-assisted coil embolization for an unruptured aneurysm located on the basilar apex artery with 2 stents (subject device).Post-procedure the patient was assessed having a mrs and nihss of 0.At the 2 and 6-month follow-up, the patient was assessed having a mrs and nihss of 0.It was reported that 7-month post-procedure, the patient experienced 3 episodes of ophthalmic migraine over a period of approximately 2 months.The patient was treated with medication and the migraine episodes were resolved no residual effects.According to the physician, the adverse event of migraine was possibly related to the procedure, the 2 stents, and the implanted coil mass.This reports concerns the first stent.
Event or Problem Description
The patient underwent successful stent-assisted coil embolization for an unruptured aneurysm located on the basilar apex artery with 2 stents (subject device).Post-procedure the patient was assessed having a mrs and nihss of 0.At the 2 and 6-month follow-up, the patient was assessed having a mrs and nihss of 0.It was reported that 7-month post-procedure, the patient experienced 3 episodes of ophthalmic migraine over a period of approximately 2 months.The patient was treated with medication and the migraine episodes were resolved no residual effects.According to the physician, the adverse event of migraine was possibly related to the procedure, the 2 stents, and the implanted coil mass.This reports concerns the first stent.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.However, complications such as ophthalmic migraine is a known risk associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 3.0 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: 7648156
• Report Number: 3008881809-2018-00288
• Device Sequence Number: 11175742
• Product Code: NJE
• UDI-Device Identifier: 07613252656159
• UDI-Public: 07613252656159
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: H020002/S046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

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: 07/31/2020
• Device Catalogue Number: M003SZAS30210
• Device Lot Number: 18526891
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 09/05/2018
• 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: 4 TARGET COILS (STRYKER); NEUROFORM ATLAS STENT (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR