MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.0 X 24MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003SZAS40240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Thrombus (2101)
Date of Event	03/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported the during implantation of the stent (subject device) into the right posterior cerebral artery (pca), the patient suffered a stroke of the distal basilar artery.The physician performed a thrombectomy and blood circulation was restored.The physician suspects that the stroke occurred due to thrombus formation in the stent lumen at the top of the basilar artery.The patient is currently hospitalized with a mid-brain stroke of score 18 on national institutes of health stroke scale (nhiss).No further information is available.
Additional Manufacturer Narrative
The automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.Based on the investigation results and available information an assignable cause of anticipated procedural complication was assigned to the as reported issue of patient stroke and thrombus formation since the issues are due to known physiological effects of the procedure and or/ patient condition noted with the direction for use, device labelling and/or risk documentation files.The subject device remains implanted in patient.
Event or Problem Description
It was reported the during implantation of the stent (subject device) into the right posterior cerebral artery (pca), the patient suffered a stroke of the distal basilar artery.The physician performed a thrombectomy and blood circulation was restored.The physician suspects that the stroke occurred due to thrombus formation in the stent lumen at the top of the basilar artery.The patient is currently hospitalized with a mid-brain stroke of score 18 on national institutes of health stroke scale (nhiss).No further information is available.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 4.0 X 24MM 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: 8510339
• Report Number: 3008881809-2019-00098
• Device Sequence Number: 1955740
• Product Code: NJE
• UDI-Device Identifier: 07613252656203
• UDI-Public: 07613252656203
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: H020002/S046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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: 01/31/2023
• Device Catalogue Number: M003SZAS40240
• Device Lot Number: 20296589
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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: EXCELSIOR MICROCATHETER (STRYKER); EXCELSIOR MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention