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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR NEUROFORM ATLAS; INTRACRANIAL COIL-ASSIST STENT
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STRYKER NEUROVASCULAR NEUROFORM ATLAS; INTRACRANIAL COIL-ASSIST STENT Back to Search Results
Model Number M003UZAS40240
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Deformation (2976)
Patient Problems Death (1802); Ruptured Aneurysm (4436)
Event Date 11/12/2020
Event Type  Death  
Event Description
Female presenting for elective stent assisted coil embolization of r ica aneurysm.Procedure complicated by stent failure and inability to embolize aneurysm with subsequent rupture.Procedure also complicated by subsequent r pca and r sca infarction (different vessel than treated during procedure).An atlas stent was initially placed in right ica for stent coiling, but it deformed when coiling was attempted.We then placed an lviis blue stent after attempts to retrieve the atlas failed.Patient was given an integrillin bolus and infusion.Sheaths were left in place.
 
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Brand Name
NEUROFORM ATLAS
Type of Device
INTRACRANIAL COIL-ASSIST STENT
Manufacturer (Section D)
STRYKER NEUROVASCULAR
47900 bayside parkway
fremont CA 94538
MDR Report Key11300551
MDR Text Key230943681
Report Number11300551
Device Sequence Number1
Product Code QCA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM003UZAS40240
Device Catalogue NumberUZAS4024
Device Lot Number21601235
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/04/2021
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer02/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age13140 DA
Patient Weight62
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