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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.5 X 21MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.5 X 21MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003EZAS45210
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Transient Ischemic Attack (2109); No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2018
Event Type  Injury  
Manufacturer Narrative
Subject device is not available.
 
Event Description
It was reported that a patient underwent successful stenting of an aneurysm located on the left internal carotid with the subject stent.Post-procedure, the patient experienced an ischemic stroke in the posterior internal carotid artery (pica) territory due to the diagnostic angiography.Mri confirms infarct 1 day-post-adverse event of stroke.The adverse event of stroke was resolved 1 day-post-adverse event without sequelae.The duration of longest deficit was less than 24 hours.According to the site, the adverse event of stroke was unrelated to the subject stent.Clinical event committee (cec) adjudication has not been completed yet.
 
Manufacturer Narrative
Event: executive summary: corrected: according to the clinical event committee (cec) adjudication, the adverse event of ischemic stroke was not related to the subject stent.Therefore, this event of stroke does not meet the reportability criteria anymore.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the subject device.
 
Event Description
It was reported that a patient underwent successful stenting of an aneurysm located on the left internal carotid with the subject stent.Post-procedure, the patient experienced an ischemic stroke in the posterior internal carotid artery (pica) territory due to the diagnostic angiography.Mri confirms infarct 1 day-post-adverse event of stroke.The adverse event of stroke was resolved 1 day-post-adverse event without sequelae.The duration of longest deficit was less than 24 hours.According to the site, the adverse event of stroke was unrelated to the subject stent.According to the clinical event committee (cec) adjudication, the adverse event of ischemic stroke was not related to the subject stent.
 
Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event could not be confirmed; however, the reported patient tia (transient ischemic attack) is a known risk associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
 
Event Description
It was reported that a patient underwent successful stenting of an aneurysm located on the left internal carotid with the subject stent.Post-procedure, the patient experienced an ischemic stroke in the posterior internal carotid artery (pica) territory due to the diagnostic angiography.Mri confirms infarct 1 day-post-adverse event of stroke.The adverse event of stroke was resolved 1 day-post-adverse event without sequelae.The duration of longest deficit was less than 24 hours.According to the site, the adverse event of stroke was unrelated to the subject stent.Clinical event committee (cec) adjudication has not been completed yet.
 
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Brand Name
NEUROFORM ATLAS STENT SYSTEM 4.5 X 21MM WITHOUT TIP
Type of Device
STENT, INTRACRANIAL NEUROVASCULAR
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
MDR Report Key9170091
MDR Text Key161811275
Report Number3008881809-2019-00307
Device Sequence Number1
Product Code NJE
Combination Product (y/n)N
PMA/PMN Number
H020002/S046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Type of Report Initial,Followup,Followup
Report Date 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/31/2022
Device Catalogue NumberM003EZAS45210
Device Lot Number19690467
Was Device Available for Evaluation? No
Date Manufacturer Received11/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age59 YR
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