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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 3.0 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 3.0 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003WE0300150
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/06/2019
Event Type  malfunction  
Manufacturer Narrative
The subject device is unavailable to manufacturer.
 
Event Description
It was reported that when deploying the subject stent to the target site, the resistance was too strong to deploy.When trying to deploy with a strong force, the inner shaft of the subject stent was broken, making it impossible to deploy.The subject stent was removed and replaced with another stent.The procedure was safely completed without clinical consequences to the patient.
 
Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned, therefore physical and functional tests could not be performed.As per the additional information, the device was confirmed to be in good condition after unpacking and preparation and it was prepared as per the device directions for use (dfu).The patient's anatomy was averagely tortuous and there was resistance encountered as the stent delivery system was advanced to the lesion.It is probable that the tortuousity caused difficulties in advancing the device to the target lesion and causing the subsequent difficulty to advance the stabilizer within the delivery catheter to deploy the flow diverter stent and fracture to the stent stabilizer.An assignable cause of procedural factors will be assigned to the reported event, 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 deploying the subject stent to the target site, the resistance was too strong to deploy.When trying to deploy with a strong force, the inner shaft of the subject stent was broken, making it impossible to deploy.The subject stent was removed and replaced with another stent.The procedure was safely completed without clinical consequences to the patient.
 
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Brand Name
F/G WINGSPAN STENT SYSTEM 3.0 X 15MM
Type of Device
STENT, INTRACRANIAL NEUROVASCULAR
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
MDR Report Key8935676
MDR Text Key155670825
Report Number3008881809-2019-00251
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 09/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/30/2021
Device Catalogue NumberM003WE0300150
Device Lot Number20766204
Was Device Available for Evaluation? No
Date Manufacturer Received09/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
TRANSEND GUIDEWIRE (STRYKER); TRANSEND GUIDEWIRE (STRYKER)
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