Catalog Number FD50025 |
Device Problem
Activation Failure (3270)
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Patient Problems
Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
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Event Date 06/15/2021 |
Event Type
Injury
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Manufacturer Narrative
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Device remains implanted in the patient.
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Event Description
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It was reported that during the procedure the flow diverting stent (subject device) did not open when deployed at the target site inside the patient's anatomy.The instruction form the direction of use of the subject stent was followed during the procedure.When the subject stent failed to open, the physician decided to deploy it completely.The physician advanced a microcatheter to recapture the subject stent and massage it gently to open the subject stent but it was unsuccessfully.The physician then decided to dilate a balloon catheter and inflated it 3 times.The physician then implanted a new stent in the proximal part of the subject stent.At this point, intra-stent thrombi were evident and medication (tirofiban) was given to the patient.A completely occluded carotid artery was observed during the procedure.Even though the patient was under 8 days of dual antiplatelet therapy (before the procedure), it was observed angiographically that the patient had collateral filling by other branches.The next day, the patient underwent angiographic control without any complications.It was reported that the patient had a prolonged hospital stay for patient vigilance.No further information is available.
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Manufacturer Narrative
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H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.It was reported that an additional stent was deployed when the proximal part of the subject flow diverting stent did not open when implanted at the target site.Formation of intra-stent thrombi was noted followed by a completely occluded carotid artery.When angiograph was performed, it was noted that the patient had collateral filling by other branches.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
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Event Description
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It was reported that during the procedure the flow diverting stent (subject device) did not open when deployed at the target site inside the patient's anatomy.The instruction form the direction of use of the subject stent was followed during the procedure.When the subject stent failed to open, the physician decided to deploy it completely.The physician advanced a microcatheter to recapture the subject stent and massage it gently to open the subject stent but it was unsuccessfully.The physician then decided to dilate a balloon catheter and inflated it 3 times.The physician then implanted a new stent in the proximal part of the subject stent.At this point, intra-stent thrombi were evident and medication (tirofiban) was given to the patient.A completely occluded carotid artery was observed during the procedure.Even though the patient was under 8 days of dual antiplatelet therapy (before the procedure), it was observed angiographically that the patient had collateral filling by other branches.The next day, the patient underwent angiographic control without any complications.It was reported that the patient had a prolonged hospital stay for patient vigilance.No further information is available.
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Search Alerts/Recalls
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