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 21MM 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 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 Stroke/CVA (1770); Paresthesia (4421)
Event Date 09/13/2017
Event Type  Injury  
Manufacturer Narrative
Device remains implanted in patient.
 
Event Description
It was reported that approximately 3 months post procedure the patient suffered a stroke that resulted in left hand paresthaesia after stopping medication.The event resolved without sequelae.The patients medical condition was good.There were no clinical consequences to the patient.
 
Manufacturer Narrative
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.
 
Event Description
It was reported that approximately 3 months post procedure the patient suffered a stroke that resulted in left hand paresthaesia after stopping medication.The event resolved without sequelae.The patients 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 approximately three months post procedure the patient suffered left hand paresthesia after the patient stopped taking the prescribed medication.Index procedure and pre-existing conditions that may have contributed to this event were stated as unrelated.Site had previously concluded that there was no stroke or neurological event but cec adjudication on (b)(6) 2020 concluded that the patient had neurological event at the anterior circulation and the duration of the longest deficit was >24horus however mri imaging shows that there is not infarct.The patient was given medication and the event was resolved, without sequelae.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
EI  NA
MDR Report Key10864996
MDR Text Key217110254
Report Number3008881809-2020-00350
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 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
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 NumberM003EZAS30210
Device Lot Number19653777
Was Device Available for Evaluation? No
Date Manufacturer Received01/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
XT-17 CATHETER (STRYKER); XT-17 CATHETER (STRYKER)
Patient Outcome(s) Other;
Patient Age72 YR
-
-