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

Catalog Number	M003UZAS30240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Intracranial Hemorrhage (1891); Nausea (1970); Confusion/ Disorientation (2553); Ischemia Stroke (4418); Embolism/Embolus (4438)
Date of Event	03/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 2 of 3 reports.
Event or Problem Description
It was reported that the patient presents to ed (emergency department) with headache, nausea and confusion on (b)(6) 2024.Magnetic resonance imaging (mri) scan on (b)(6) 2024 shows acute multifocal punctate cerebellar stroke and acute sah (sub arachnoid hemorrhage).According to the physician, the adverse events were related to retreatment of the aneurysm with stent/coil embolization on (b)(6) 2024.Cannot specify if it was related specifically to the subject stent or coils.The outcome was resolved without sequelae.
Event or Problem Description
It was reported that the patient presents to ed (emergency department) with headache, nausea and confusion on (b)(6) 2024.Magnetic resonance imaging (mri) scan on (b)(6) 2024 shows acute multifocal punctate cerebellar stroke and acute sah (sub arachnoid hemorrhage).According to the physician, the adverse events were related to retreatment of the aneurysm with stent/coil embolization on (b)(6) 2024.Cannot specify if it was related specifically to the subject stent or coils.The outcome was resolved without sequelae.
Additional Manufacturer Narrative
D2a common device name- corrected 'intracranial coil-assist stent.' d2b product code: corrected to 'qca.' d4 gtin: corrected to (b)(4), d4 expiration date - added.H4 manufacturing date ¿ added.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject stent device is not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the subject stent device was not returned.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.Additional information provided by the customer indicated the there were adverse consequences to the patient resulting in headache, nausea, confusion, stroke, ischemic, ipsilateral distal vessel, embolic minor requiring new hospitalization.The patient remains in hospital.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.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 within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to the reported 'patient stroke¿, 'patient headache serious', 'patient intercranial hemorrhage' and 'patient neurological deficit'.

• Brand Name: NEUROFORM ATLAS 3.0MM X 24MM NO TIP- PMA
• Common Device Name: INTRACRANIAL COIL-ASSIST STENT
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 19967795
• Report Number: 3008881809-2024-00365
• Device Sequence Number: 8897629
• Product Code: QCA
• UDI-Device Identifier: 07613327382204
• UDI-Public: (01)07613327382204(17)280806(10)24476556
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P180031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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: M003UZAS30240
• Device Lot Number: 24476556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 71 YR
• Patient Sex: Female