Catalog Number M003WE0300150 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/06/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device is unavailable to manufacturer.
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Event Description
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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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Manufacturer Narrative
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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.
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Event Description
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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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Search Alerts/Recalls
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