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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 2.5 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 2.5 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003WS0250150
Device Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2019
Event Type  Injury  
Event Description
It was reported that during the procedure, the subject stent was delivered to target lesion and deployed successfully.However underlying stenosis had caused serious narrowing in the middle of the stent that when the inter-body of delivery system was attempted to be withdrawn, the inner body would not pull back through the stent.Stenosis was so tight that the physician was unable to advance outer body through the stent to capture the inter-body.The reason as to why the inner body would not pull through or withdraw through the deployed stent was unknown.This caused the physician to use a scissors to cut the inner body at the rhv points and remove the entire system through the stent.This event resulted in a forty five minute surgical delay.The procedure was completed successfully and no clinical consequences were reported to the patient due to this event.
 
Manufacturer Narrative
There was no packaging returned with the device, therefore it cannot be confirmed that the correct device was returned.During visual inspection, the hub of the stabilizer was detached (cut by physician during use).There was blood noted within the delivery catheter and the hub/rhv.No other anomalies were noted.During functional inspection, the delivery catheter was flushed and submerged in warm water in an attempt to remove the stabilizer, however dried blood within the system prevented this.The stabilizer was unable to be removed from the catheter.The reported complaint was confirmed based on analysis as it was found.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported issue is covered in the device directions for use (dfu).As well, the risk of the reported issue is documented in the risk documentation and there are current controls to mitigate the risk of the reported issue.As per the additional information underlying stenosis caused serious narrowing in the middle of the stent.It is probable that the narrowing of the stent due to stenosis caused the difficulty experienced during the clinical procedure.An assignable cause of procedural factors will be assigned to the reported and analyzed events, 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 during the procedure, the subject stent was delivered to target lesion and deployed successfully.However underlying stenosis had caused serious narrowing in the middle of the stent that when the inter-body of delivery system was attempted to be withdrawn, the inner body would not pull back through the stent.Stenosis was so tight that the physician was unable to advance outer body through the stent to capture the inter-body.The reason as to why the inner body would not pull through or withdraw through the deployed stent was unknown.This caused the physician to use a scissors to cut the inner body at the rhv points and remove the entire system through the stent.This event resulted in a forty five minute surgical delay.The procedure was completed successfully and no clinical consequences were reported to the patient due to this event.
 
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Brand Name
F/G WINGSPAN STENT SYSTEM 2.5 X 15MM
Type of Device
STENT, INTRACRANIAL NEUROVASCULAR
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
IE  NA
MDR Report Key9533409
MDR Text Key176098774
Report Number3008881809-2019-00414
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 04/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/16/2021
Device Catalogue NumberM003WS0250150
Device Lot Number201474896
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2019
Date Manufacturer Received03/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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