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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN STENT SYSTEM 4.0MM X 20MM - CE; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK WINGSPAN STENT SYSTEM 4.0MM X 20MM - CE; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003WE0400200
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/26/2019
Event Type  malfunction  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that when the stent (subject device) was delivered to the lesion during the procedure, the inner shaft broke during deployment.The physician proceeded to withdraw the stent and replace it with a new stent.The procedure continued and completed the procedure successfully without clinical consequences to the patient.
 
Manufacturer Narrative
H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated 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 subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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.As per the event description there were no anomalies noted to the device prior to use and the device was prepared as per the dfu.The patient¿s anatomy was quite tortuous.It is probable that the device was damaged during advancement through the patients anatomy.An assignable cause of procedural factors will be assigned to the reported ¿stent stabilizer broken/fractured during use¿, as the issue is associated with a product that meets stryker 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 when the stent (subject device) was delivered to the lesion during the procedure, the inner shaft broke during deployment.The physician proceeded to withdraw the stent and replace it with a new stent.The procedure continued and completed the procedure successfully without clinical consequences to the patient.
 
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Brand Name
WINGSPAN STENT SYSTEM 4.0MM X 20MM - CE
Type of Device
STENT, INTRACRANIAL NEUROVASCULAR
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
IE  NA
MDR Report Key9613221
MDR Text Key176664306
Report Number3008881809-2020-00011
Device Sequence Number1
Product Code NJE
Combination Product (y/n)N
PMA/PMN Number
H050001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/18/2022
Device Catalogue NumberM003WE0400200
Device Lot Number21444722
Was Device Available for Evaluation? No
Date Manufacturer Received02/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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