MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 3.0 X 15MM WITH TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003STAS30150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	10/15/2018
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 was not returned for analysis; therefore, physical as well as a functional testing could not be performed.However, in-stent stenosis 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.This is the first of 2 reports.Subject device remains implanted.
Event or Problem Description
It was reported that at the 12 month-follow-up a successful stent-assisted coil embolization procedure, the digital subtraction angiography (dsa) showed that left occluded "culprit" artery (oca) was nondominant and appears occluded intrastent (100%).Large patent left posterior communicating artery (pcom) supplies left posterior cerebral artery (pca) territory basilar artery and right pca stents (subject device) are patent.There were no clinical consequences to the patient.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 3.0 X 15MM WITH TIP
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8148796
• Report Number: 3008881809-2018-00520
• Device Sequence Number: 13804496
• Product Code: NJE
• UDI-Device Identifier: 07613252656005
• UDI-Public: 07613252656005
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 12/10/2018

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: 01/31/2021
• Device Catalogue Number: M003STAS30150
• Device Lot Number: 18798584
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/10/2018
• 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: NEUROFORM ATLAS STENT (STRYKER)
• Patient Age: 53 YR