MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 24MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS40240

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infarction, Cerebral (1771); Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 09/02/2018

Event Type  Injury  

Manufacturer Narrative

Subject device remains implanted.

Event Description

It was reported that the stent (subject device) was successfully implanted for an aneurysm located at the left anterior cerebral, at anterior communicating junction.12-16-month visit indicated 100% in-stent stenosis and parent vessel stenosis.Approximately 1 year 5 month-post-procedure the patient experienced motor deficit of the right leg (national institutes of health stroke scale (nihss) was 2) related to an ischemic stroke.Magnetic resonance imaging (mir) confirmed cerebral infract next day.The stroke was resolved without sequalae 1 month post adverse event.According to the physician, the ischemic stroke was to the subject stent and to the procedure.

Event Description

It was reported that the stent (subject device) was successfully implanted for an aneurysm located at the left anterior cerebral, at anterior communicating junction.12-16-month visit indicated 100% in-stent stenosis and parent vessel stenosis.Approximately 1 year 5 month-post-procedure the patient experienced motor deficit of the right leg (national institutes of health stroke scale (nihss) was 2) related to an ischemic stroke.Magnetic resonance imaging (mir) confirmed cerebral infract next day.The stroke was resolved without sequalae 1 month post adverse event.According to the physician, the ischemic stroke was to the subject stent and to the procedure.

Manufacturer Narrative

D4: expiration date: updated.H4: manufacturing date: updated.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 subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported issue is covered in the device directions for use.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 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.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 Description

It was reported that the stent (subject device) was successfully implanted for an aneurysm located at the left anterior cerebral, at anterior communicating junction.12-16-month visit indicated 100% in-stent stenosis and parent vessel stenosis.Approximately 1 year 5 month-post-procedure the patient experienced motor deficit of the right leg (national institutes of health stroke scale (nihss) was 2) related to an ischemic stroke.Magnetic resonance imaging (mir) confirmed cerebral infract next day.The stroke was resolved without sequalae 1 month post adverse event.According to the physician, the ischemic stroke was to the subject stent and to the procedure.Additional information received on 02-sept- 2020 from device observation form disclosed that the stent (subject device) thrombosis/occlusion malfunction and resulted in development of ischemic stroke in the patient.

Manufacturer Narrative

Due to the automated mes 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.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.The reported events are known and anticipated complications to these types of procedures and patient condition and are listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complication will be assigned to this event.

• Brand Name: NEUROFORM ATLAS 4.0MM X 24MM NO TIP - CE
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 9742219
• MDR Text Key: 180619078
• Report Number: 3008881809-2020-00049
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: M003EZAS40240
• Device Lot Number: 19209301
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEADWAY 17 CATHETER (MICRO VENTION INC.)
• Patient Outcome(s): Other
• Patient Age: 55 YR