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 Codes	Neurological Deficit/Dysfunction (1982); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 2 of 2 reports.Subject device remains implanted.
Event or Problem Description
It was reported that a patient underwent successful stent-assisted (y-stenting) coil embolization of an unruptured aneurysm located on the basilar apex.Approximately 8 month-post-procedure, re- intervention to target aneurysm was undertaken.The event was resolved with no residual effects.According to the clinical events committee (cec), the re-treatment was related to the procedure, related to the atlas stents (subject devices), and not related to the coil mass.Per site, the reason for the re-intervention was a large, expanding basilar aneurysm with compression on the brainstem causing symptoms.Aneurysm continued to expand despite atlas stenting and coiling.
Additional Manufacturer Narrative
Outcomes attributed to ae: added "other serious (important medical events)".Executive summary: based on the additional information received executive summary is updated to include, ¿per site, the reason for the re-intervention was a large, expanding basilar aneurysm with compression on the brainstem causing symptoms.¿ (b)(4).
Event or Problem Description
It was reported that a patient underwent successful stent-assisted (y-stenting) coil embolization of an unruptured aneurysm located on the basilar apex.Approximately 8 month-post-procedure, re- intervention to target aneurysm was undertaken.The event was resolved with no residual effects.According to the clinical events committee (cec), the re-treatment was related to the procedure, related to the atlas stents (subject devices), and not related to the coil mass.Per site, the reason for the re-intervention was a large, expanding basilar aneurysm with compression on the brainstem causing symptoms.
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.In the case of this complaint it was reported that the patient had to go re-treatment of aneurysm 8 months after the stenting and coiling procedure due to aneurysm still expanding.However, recanalization requiring retreatment is a 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.Update: additional information received mentioned that the symptoms were "right sided weakness".Expiration date: added.Manufacturing date: added.
Event or Problem Description
It was reported that a patient underwent successful stent-assisted (y-stenting) coil embolization of an unruptured aneurysm located on the basilar apex.Approximately 8 month-post-procedure, re- intervention to target aneurysm was undertaken.The event was resolved with no residual effects.According to the clinical events committee (cec), the re-treatment was related to the procedure, related to the atlas stents (subject devices), and not related to the coil mass.Per site, the reason for the re-intervention was a large, expanding basilar aneurysm with compression on the brainstem causing symptoms of right sided weakness.After retreatment, at 8+ month post-procedure, the right sided weakness was ongoing.

• 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: 7676263
• Report Number: 3008881809-2018-00300
• Device Sequence Number: 10974736
• Product Code: NJE
• UDI-Device Identifier: 07613252656159
• UDI-Public: 07613252656159
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2018

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: 07/31/2021
• Device Catalogue Number: M003SZAS30210
• Device Lot Number: 19218065
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 06/18/2018; 08/06/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 07/17/2018; 08/17/2018
• 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; Required Intervention
• Patient Age: 54 YR