MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.0 X 21MM WITH TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003STAS40210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Transient Ischemic Attack (2109)
Date of Event	08/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the first of 2 reports.Subject device remains implanted.
Event or Problem Description
It was reported that approximately 5 month-post successful stent-assisted coil embolization of an aneurysm located on the basilar apex, the patient suffered a transient ischemic attack (tia).Treatment was required with hospitalization/prolonged hospitalization.The adverse event was resolved without residual effects.According to the clinical events committee (cec), the tia was related to the atlas stent (subject device).According to the site, the tia was related to pre-existing condition/co-morbidity/medication.
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, patient tia (transient ischemic attack) is a known risk 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.Expiration date: added.Manufacturing date: added.
Event or Problem Description
It was reported that approximately 5 month-post successful stent-assisted coil embolization of an aneurysm located on the basilar apex, the patient suffered a transient ischemic attack (tia).Treatment was required with hospitalization/prolonged hospitalization.The adverse event was resolved without residual effects.According to the clinical events committee (cec), the tia was related to the atlas stent (subject device).According to the site, the tia was related to pre-existing condition/co-morbidity/medication.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 4.0 X 21MM 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: 7704615
• Report Number: 3008881809-2018-00311
• Device Sequence Number: 1451956
• Product Code: NJE
• UDI-Device Identifier: 07613252656074
• UDI-Public: 07613252656074
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: H020002/S046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2018

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: M003STAS40210
• Device Lot Number: 18798588
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR