MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 24MM NO TIP- PMA; STENT, INTRACRANIAL NEUROVASCULAR

Model Number	M003UZAS30240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neurological Deficit/Dysfunction (1982)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device remains implanted.
Event or Problem Description
It was reported that approximately 3 months post stent-assisted coiling procedure with the subject stent for an aneurysm located in the right middle cerebral, at main branching (trifurcation), the patient experienced dysarthria and aphasia of sudden appearance.Suspected causes were migraines, epileptic event, delay in endothelization of the subject stent.Medication was administered to the patient.The adverse event of neurological deficit of dysarthria and aphasia spontaneously resolved without sequelae approximately 3 months post-procedure.According to the physician, the adverse event was serious, and it is unknown if the adverse event was related to the subject device, medication, or pre-existing condition.Additional information has been requested.
Additional Manufacturer Narrative
The intended use for the device was for treatment.The reported complaint could not be confirmed and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.An assignable cause of anticipated procedural complication will be assigned to the reported event as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.
Event or Problem Description
It was reported that approximately 3 months post stent-assisted coiling procedure with the subject stent for an aneurysm located in the right middle cerebral, at main branching (trifurcation), the patient experienced dysarthria and aphasia of sudden appearance.Suspected causes were migraines, epileptic event, delay in endothelization of the subject stent.Medication was administered to the patient.The adverse event of neurological deficit of dysarthria and aphasia spontaneously resolved without sequelae approximately 3 months post-procedure.According to the physician, the adverse event was serious, and it is unknown if the adverse event was related to the subject device, medication, or pre-existing condition.Additional information has been requested.

• Brand Name: NEUROFORM ATLAS 3.0MM X 24MM NO TIP- PMA
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10295889
• Report Number: 3008881809-2020-00213
• Device Sequence Number: 16807973
• Product Code: NJE
• UDI-Device Identifier: 07613327382204
• UDI-Public: 07613327382204
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P180031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2020

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: No Information
• Device Expiration Date: 05/31/2022
• Device Model Number: M003UZAS30240
• Device Catalogue Number: M003UZAS30240
• Device Lot Number: 19780677
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 09/20/2020
• 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: 39 YR