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 4.0MM X 24MM 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 4.0MM X 24MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003EZAS40240
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Headache (1880); Loss of Vision (2139); Loss of consciousness (2418)
Event Date 01/28/2019
Event Type  Death  
Manufacturer Narrative
Device remains implanted in patient.
 
Event Description
It was reported in the clinical trail that post procedure the patient suffered a headache followed by visual loss, loss of consciousness and sudden death.No autopsia, nor images were taken.The patient medical condition was good.There were no clinical consequences to the patient.
 
Event Description
It was reported in the clinical trail that post procedure the patient suffered a headache followed by visual loss, loss of consciousness and sudden death.No autopsia, nor images were taken.The patient medical condition was good.There were no clinical consequences to the patient.Correction for previous executive summary: it was reported in the clinical trial that two hours after the patient arrived at their home on (b)(6) 2019, they suffered a headache followed by visual loss, loss of consciousness and sudden death.No autopsy was performed, no images taken due to this event.Pre-existing conditions or medication given that may have contributed to this event are unknown.Site had previously concluded that patient death was not related to subject device but cec adjudication on (b)(6) 2021 concluded that relationship between subject device and patient death is unknown.
 
Manufacturer Narrative
B2: outcomes attributed to ae - corrected.B5: executive summary ¿ corrected.H1: type of reportable event and event type - corrected.H4: manufacturing date ¿ added.D4: expiration date ¿ added.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.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 event was unable to be confirmed and it cannot be confirmed that the device met specification, as 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.H3 other text : device remains implanted in patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11077884
MDR Text Key223790828
Report Number3008881809-2020-00405
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
Type of Report Initial,Followup
Report Date 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Catalogue NumberM003EZAS40240
Device Lot Number20162778
Was Device Available for Evaluation? No
Date Manufacturer Received02/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
HEADWAY DUO CATHETER (MICRO VENTION INC.).; HEADWAY DUO CATHETER (MICRO VENTION INC.)
Patient Outcome(s) Death; Other;
Patient Age72 YR
-
-