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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003EZAS30210
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Infarction, Cerebral (1771); Thrombosis (2100)
Event Date 05/31/2017
Event Type  Injury  
Manufacturer Narrative
This is the second of 2 reports.Subject device remains implanted.
 
Event Description
It was reported that a patient underwent 2 different stent-assisted coiling procedures for 2 different aneurysms with the subject stents.First procedure was a successful stent-assisted coiling for an aneurysm located left middle cerebral, at main branching (bifurcation) approximately 1 month-pre second procedure.The second procedure was a successful stent-assisted coiling for another aneurysm located at the same location as the first procedure.1 day post-second procedure, the patient experienced ischemic stroke with dysarthria and left facial palsy related to in stent thrombosis.Magnetic resonance imaging (mri) confirmed ischemic lesions.Aspiration and medication were used to resolve in stent thrombosis.The ischemic stroke was resolved, without sequelae 6-day-post adverse event.According to the physician, the adverse event of ischemic stroke was related to the subject stents.
 
Manufacturer Narrative
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 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 a patient underwent 2 different stent-assisted coiling procedures for 2 different aneurysms with the subject stents.First procedure was a successful stent-assisted coiling for an aneurysm located left middle cerebral, at main branching (bifurcation) approximately 1 month-pre second procedure.The second procedure was a successful stent-assisted coiling for another aneurysm located at the same location as the first procedure.1 day post-second procedure, the patient experienced ischemic stroke with dysarthria and left facial palsy related to in stent thrombosis.Magnetic resonance imaging (mri) confirmed ischemic lesions.Aspiration and medication were used to resolve in stent thrombosis.The ischemic stroke was resolved, without sequelae 6-day-post adverse event.According to the physician, the adverse event of ischemic stroke was related to the subject stents.
 
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Brand Name
NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE
Type of Device
STENT, INTRACRANIAL NEUROVASCULAR
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
IE  NA
MDR Report Key9914389
MDR Text Key186203519
Report Number3008881809-2020-00085
Device Sequence Number1
Product Code NJE
Combination Product (y/n)N
PMA/PMN Number
P180031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Type of Report Initial,Followup
Report Date 04/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2022
Device Catalogue NumberM003EZAS30210
Device Lot Number19611386
Was Device Available for Evaluation? No
Date Manufacturer Received04/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NEUROFORM ALTAS STENT (STRYKER)
Patient Outcome(s) Other; Required Intervention;
Patient Age49 YR
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