Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003EZAS30150
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Infarction, Cerebral (1771); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2019
Event Type  Death  
Manufacturer Narrative
Subject device remains implanted.
 
Event Description
It was reported that a stent (subject device) was successfully implanted for an aneurysm located at the right middle cerebral artery (mca), at the main branch (trifurcation).Modified raymond scale post procedure was class 1.Approximately 2 year-post- procedure, the patient experienced an ischemic stroke; there was slow flow into the parietal branch covered by the subject stent observed by dsa.The patient has been experiencing left arm sensitive deficit for one year.According to the physician, the adverse event of ischemic stroke is most likely related to the implanted subject stent and not the vessel.Patient outcome is ongoing.
 
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 reported event is covered in the device 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 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.
 
Event Description
It was reported that a stent (subject device) was successfully implanted for an aneurysm located at the right middle cerebral artery (mca), at the main branch (trifurcation).Modified raymond scale post procedure was class 1.Approximately 2 year-post- procedure, the patient experienced an ischemic stroke; there was slow flow into the parietal branch covered by the subject stent observed by dsa.The patient has been experiencing left arm sensitive deficit for one year.According to the physician, the adverse event of ischemic stroke is most likely related to the implanted subject stent and not the vessel.Patient outcome is ongoing.
 
Manufacturer Narrative
The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.H3 other text : device remains implanted in patient.
 
Event Description
It was reported that a stent (subject device) was successfully implanted for an aneurysm located at the right middle cerebral artery (mca), at the main branch (trifurcation).Modified raymond scale post procedure was class 1.Approximately 2 year-post- procedure, the patient experienced an ischemic stroke; there was slow flow into the parietal branch covered by the subject stent observed by dsa.The patient has been experiencing left arm sensitive deficit for one year.According to the physician, the adverse event of ischemic stroke is most likely related to the implanted subject stent and not the vessel.Patient outcome is ongoing.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NEUROFORM ATLAS 3.0MM X 15MM 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 Key9736259
MDR Text Key180618805
Report Number3008881809-2020-00046
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 health professional,study
Type of Report Initial,Followup,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2021
Device Catalogue NumberM003EZAS30150
Device Lot Number19248216
Was Device Available for Evaluation? No
Date Manufacturer Received12/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age43 YR
-
-