MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 30MM NO TIP- PMA; STENT, INTRACRANIAL NEUROVASCULAR

Model Number	M003UZAS40300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	02/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device remains implanted.
Event or Problem Description
It was reported that during stent-assisted coiling procedure for an aneurysm located at the right middle cerebral artery (mca), at main branching (trifurcation) with the subject stent, there was stent thrombosis due to platelet aggregation to the ostium of the stented branch.Resolved after injection of abciximab medication.According to the physician, the adverse event of stent thrombosis was assessed as serious adverse event and related to the subject stent and the index procedure.The adverse event was resolved without sequelae.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was intended to be used for treatment.The reported event was unable to be confirmed and it cannot be confirmed that the device net specification, as the 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.The device was not returned.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 during stent-assisted coiling procedure for an aneurysm located at the right middle cerebral artery (mca), at main branching (trifurcation) with the subject stent, there was stent thrombosis due to platelet aggregation to the ostium of the stented branch.Resolved after injection of abciximab medication.According to the physician, the adverse event of stent thrombosis was assessed as serious adverse event and related to the subject stent and the index procedure.The adverse event was resolved without sequelae.

• Brand Name: NEUROFORM ATLAS 4.0MM X 30MM 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: 10242106
• Report Number: 3008881809-2020-00197
• Device Sequence Number: 19543429
• Product Code: NJE
• UDI-Device Identifier: 07613327382181
• UDI-Public: 07613327382181
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P180031
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: M003UZAS40300
• Device Catalogue Number: M003UZAS40300
• Device Lot Number: 20226716
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 10/06/2020
• 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: 59 YR