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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003EZAS40210
Device Problem Activation Failure (3270)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2020
Event Type  malfunction  
Manufacturer Narrative
Device is not available to manufacturer.
 
Event Description
It was reported that the stent (subject device) did not open when implanted at the target location inside the patient's anatomy during the procedure.A guidewire was found wrapped in the mesh of the subject stent therefore, there was difficulty removing the subject stent.The physician used the delivery wire of the subject stent to remove it along with a guidewire and a microcatheter.The subject stent was removed successfully removed from the patient's anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the deployed stent was returned entangled in the distal end of an unknown guidewire within the distal tip of an unknown microcatheter and the struts were entangled at the distal end preventing it from opening fully.There was deformation noted to the stent.A functional test was unable to be performed due to the condition of the device.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The analyzed 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 analyzed event.As per the additional information, there was very high tortuosity.It is probable that the stent distal end was damaged during navigation through the tortuous anatomy causing the reported failure of the stent to open when it was deployed.An assignable cause of procedural factors will be assigned to the reported and to the analyzed events as the issue is associated with a product that meets design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
 
Event Description
It was reported that the stent (subject device) did not open when implanted at the target location inside the patient's anatomy during the procedure.A guidewire was found wrapped in the mesh of the subject stent therefore, there was difficulty removing the subject stent.The physician used the delivery wire of the subject stent to remove it along with a guidewire and a microcatheter.The subject stent was removed successfully removed from the patient's anatomy.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 4.0MM 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 Key10484007
MDR Text Key205365824
Report Number3008881809-2020-00252
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 11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/14/2023
Device Catalogue NumberM003EZAS40210
Device Lot Number20951555
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2020
Date Manufacturer Received11/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MICROCATHERER (UNKNOWN MANUFACTURER); TRANSEND GUIDEWIRE (STRYKER); MICROCATHERER (UNKNOWN MANUFACTURER); TRANSEND GUIDEWIRE (STRYKER)
Patient Age51 YR
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