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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN STENT SYSTEM 3.0MM X 20MM - CE; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK WINGSPAN STENT SYSTEM 3.0MM X 20MM - CE; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003WE0300200
Device Problem Fracture (1260)
Patient Problems Infarction, Cerebral (1771); Intracranial Hemorrhage (1891); Perforation (2001); Thrombosis (2100); Device Embedded In Tissue or Plaque (3165)
Event Date 05/21/2020
Event Type  Injury  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that during procedure, the subject stent was deployed at the target lesion.However, upon retraction, the subject stent delivery system could not be taken out.The operator thought that the tip of the delivery pole was stuck within the subject stent.After several removal attempts, the tapered tip of the subject stent delivery system fractured and was left in patient¿s vessel.When trying to take the tip fragment out, the stent thrombosed and hemorrhage of the basilar artery perforator vessel occurred.A two hour surgical delay occurred due to the event.The patient was treated by drug post procedure and a second procedure to remove the fragment was not planned.No further information is currently available.
 
Manufacturer Narrative
Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 additional information, when withdrawing the delivery system, big friction was caused.It is probable that there were some procedural or anatomical factors present during the clinical procedure which caused the distal tip of the delivery wire/stabilizer to become caught and breaking during the subsequent attempts to try to remove the stuck stabilizer and causing the reported patient harms and death.An probable assignable cause of procedural factors will be assigned to the reported device damage and patient harms, 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 procedure, the subject stent was deployed at the target lesion.However, upon retraction, the subject stent delivery system could not be taken out.The operator thought that the tip of the delivery pole was stuck within the subject stent.After several removal attempts, the tapered tip of the subject stent delivery system fractured and was left in patient¿s vessel.When trying to take the tip fragment out, the stent thrombosed and hemorrhage of the basilar artery perforator vessel occurred.A two hour surgical delay occurred due to the event.The patient was treated by drug post procedure and a second procedure to remove the fragment was not planned.No further information is currently available.
 
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Brand Name
WINGSPAN STENT SYSTEM 3.0MM 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 Key10169689
MDR Text Key195700907
Report Number3008881809-2020-00178
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 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/19/2022
Device Catalogue NumberM003WE0300200
Device Lot Number21464174
Was Device Available for Evaluation? No
Date Manufacturer Received08/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GATEWAY BALLOON CATHETER (STRYKER); TRANSEND GUIDEWIRE (STRYKER)
Patient Age64 YR
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