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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 15MM - CE; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK WINGSPAN STENT SYSTEM 3.0MM X 15MM - CE; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003WE0300150
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/11/2019
Event Type  malfunction  
Manufacturer Narrative
The subject device is not available to the manufacturer.
 
Event Description
It was reported that the subject stent was unable to deploy at the lesion after multiple attempts and due to friction, the stent delivery pole got fractured around the middle cerebral artery inside the patient's anatomy during the procedure.The physician then withdrew the subject stent with the 3m guidewire and replaced it with a new stent to complete the procedure successfully.There were no reported clinical consequences to the patient.
 
Event Description
It was reported that the subject stent was unable to deploy at the lesion after multiple attempts and due to friction, the stent delivery pole got fractured around the middle cerebral artery inside the patient's anatomy during the procedure.The physician then withdrew the subject stent with the 3m guidewire and replaced it with a new stent to complete the procedure successfully.There were no reported clinical consequences to the patient.
 
Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned and the reported lot number was confirmed from the returned packaging.The visual analysis revealed that the proximal 21cm section of the stabilizer was fractured and kinked, the stent was partially deployed from the distal end of the delivery catheter and the distal section of the delivery catheter was flattened.Functional analysis revealed that the catheter was flushed, and a lot of blood exited, the stabilizer was unable to be advanced through the catheter due to the damage noted, the stent was removed from the catheter and no anomalies were noted.The reported stent fracture was not confirmed, however the event was confirmed based on the damage noted to the device.The reported ar is covered in the device directions for use.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.Additional information indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and it was prepared as per the dfu.The patients anatomy was severely tortuous.The device was returned and it was confirmed that the stent stabilizer was fractured rather than the stent.The damage sustained to the device is consistent with advancing the device through the severely tortuous anatomy.The damage sustained to the device would have caused the difficulty to deploy the stent.An assignable cause of "procedural factors" will be assigned to the reported "stent failed/ unable to deploy" and to the analysed "stent stabilizer broken/fractured inside patient", "stent stabilizer kinked/ bent", "stent partial deployment", "stent delivery catheter flat/crushed" and "stent stabilizer/catheter friction", 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.An assignable cause of "not confirmed" will be assigned to the reported "stent broken/fractured during use", as it was confirmed that it was the stent stabilizer that was fractured rather than the stent.
 
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Brand Name
WINGSPAN STENT SYSTEM 3.0MM X 15MM - 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 Key9703473
MDR Text Key179336604
Report Number3008881809-2020-00038
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 05/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/30/2022
Device Catalogue NumberM003WE0300150
Device Lot Number21191325
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2020
Initial Date Manufacturer Received 02/07/2020
Initial Date FDA Received02/12/2020
Supplement Dates Manufacturer Received04/29/2020
Supplement Dates FDA Received05/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GATEWAY BALLOON CATHETER(STRYKER)
Patient Age62 YR
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