Catalog Number UNK_NEU |
Device Problem
Activation Failure (3270)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/26/2019 |
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 during aneurysm treatment, it was very difficult anatomy due to double twisting of cavernous ica (internal carotid artery).The subject flow diverter stent was initially opened well but in the tight curve; therefore, it didn't open whatever manipulation was done.The physician decided to open a new flow diverter stent and the procedure was completed without clinical consequence to the patient.
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Event Description
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It was reported that during aneurysm treatment, it was very difficult anatomy due to double twisting of cavernous ica (internal carotid artery).The subject flow diverter stent was initially opened well but in the tight curve; therefore, it didn't open whatever manipulation was done.The physician decided to open a new flow diverter stent and the procedure was completed without clinical consequence to the patient.
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Manufacturer Narrative
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The neurovascular stryker surpass evolve device is not currently not approved or commercially sold in the usa.The event for the surpass evolve device was filed to fda as a similar product to stryker device surpass streamline device that is commercially available in the us (pma # p170024).See section 4.11.3 guidance for industry and food and drug administration staff, (b)(6) 2016.
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Manufacturer Narrative
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A review of the device history record confirmed that the device met all material, assembly and performance specifications.The subject device was not returned, therefore, neither physical or functional evaluation could be performed.Based on the reported event description stated that 'the physician reported the fact that it was very difficult anatomy due to double twisting of cavernous ica (internal carotid artery).The subject device was initially opened well but in the tight curve it didn't open whatever manipulation was done'.It is probable that the anatomical factors present during the clinical procedure caused the reported failure to open the subject device.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 manufacturer specifications and was used in according with the device directions for use (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 during aneurysm treatment, it was very difficult anatomy due to double twisting of cavernous ica (internal carotid artery).The subject flow diverter stent was initially opened well but in the tight curve; therefore, it didn't open whatever manipulation was done.The physician decided to open a new flow diverter stent and the procedure was completed without clinical consequence to the patient.
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Manufacturer Narrative
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B1: adverse event/product problem: not applicable h1: type of reportable event: not applicable due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device 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.No anomalies were noted to the device prior to the procedure and the dfu was followed during the preparation of the device.As per the event description, 'the physician reported the fact that it was very difficult anatomy due to double twisting of cavernous ica.4x20mm evolve initially opened well but in the tight curve it didn't open whatever manipulation was done'.It is probable that the anatomical factors present during the clinical procedure caused the reported failure to open the stent.An assignable cause of procedural factors will be assigned to the reported event, as the issue is associated with a product that meets 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.Non-reportable rationale: based on further review, the reported event description, the subject flow diverter failed to open but was recaptured by the operator and successfully removed from the patient¿s body.The physician did not take any action/ intervention due to this event.There was no reported permanent impairment of a body function or permanent damage to a body structure, no medical or surgical intervention to prevent permanent impairment of a body function or structure was performed and the event was not life threatening.There was no information to reasonably suggest that this type of malfunction would likely cause or contribute to a death or serious injury if the malfunction were to reoccur.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the subject device.
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Event Description
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It was reported that during aneurysm treatment, it was very difficult anatomy due to double twisting of cavernous ica (internal carotid artery).The subject flow diverter stent was initially opened well but in the tight curve; therefore, it didn't open whatever manipulation was done.The physician decided to open a new flow diverter stent and the procedure was completed without clinical consequence to the patient.
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Search Alerts/Recalls
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