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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
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STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003EZAS30210
Device Problems Device Misassembled During Manufacturing /Shipping (2912); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2020
Event Type  malfunction  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that during the procedure while expanding the subject stent it was noticed that its proximal tip was unable to fully open and it was also observed by angio that the 2 markers were overlapped.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
Manufacturer Narrative
Device code was updated.H4 manufacturing date added.D4 expiration date added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 device was not returned for analysis and therefore the as reported cannot be confirmed and as assignable cause of undeterminable will be assigned to the investigation.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.
 
Event Description
It was reported that during the procedure while expanding the subject stent it was noticed that its proximal tip was unable to fully open and it was also observed by angio that the 2 markers were overlapped.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
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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 Key10782814
MDR Text Key214591535
Report Number3008881809-2020-00331
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 12/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberM003EZAS30210
Device Lot Number21908778
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 Age84 YR
Patient Weight70
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