MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 3.0 X 15MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003SZAS30150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Infarction, Cerebral (1771); Embolus (1830); Thrombosis (2100)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record (dhr) could not be performed because the batch remains unknown.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.However, stent thrombosis, embolus, and infarcts/stroke 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 a patient underwent successful stenting for an aneurysm located at the middle cerebral artery (mca).At the 6 month-follow up visit, in-stent thrombosis was observed with watershed infarct in anterior cerebral artery (aca) territory.According to the physician, the reason for the in-stent thrombosis, and infarct was that the patient had been taken off anti-platelet therapy too soon for another surgery.The patient was placed back on platelet aggregation inhibitor (brilinta) treatment.
Additional Manufacturer Narrative
Although the dhr could not be reviewed because the batch remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.However, thrombosis and infarcts/stroke 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.(b)(4).Based on safety review on (b)(6) 2018, there was only thrombosis and no embolus.
Event or Problem Description
It was reported that a patient underwent successful stenting for an aneurysm located at the middle cerebral artery (mca).At the 6 month-follow up visit, in-stent thrombosis was observed with watershed infarct in anterior cerebral artery (aca) territory.According to the physician, the reason for the in-stent thrombosis, and infarct was that the patient had been taken off anti-platelet therapy too soon for another surgery.The patient was placed back on platelet aggregation inhibitor (brilinta) treatment.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 3.0 X 15MM 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: 8081378
• Report Number: 3008881809-2018-00492
• Device Sequence Number: 13507127
• Product Code: NJE
• UDI-Device Identifier: 07613252656142
• UDI-Public: 07613252656142
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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 Catalogue Number: M003SZAS30150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 12/18/2018
• 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