Model Number SR-0840-CS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Obstruction/Occlusion (2422); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
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Event Date 10/19/2023 |
Event Type
Injury
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Manufacturer Narrative
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The product associated with this complaint was not returned to the manufacturer for analysis.A review of the manufacturing records for this device was completed and no issues were identified that could have led to the adverse event reported.There is no indication that a malfunction of the srm device occurred.At this time, it is unknown if the reported event is related to medication/patient response (plavix resistance), a procedural issue, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.Complaints will continue to be reviewed and monitored for trends.All reasonably available information has been provided by the company at the time of submission of this report.The fields that are blank are not an omission and indicate that the information is either not applicable or currently unavailable.If additional information is received, a supplemental report will be filed.
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Event Description
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It was reported that hours after the successful completion of a transcarotid artery revascularization (tcar) procedure, the patient experienced stroke symptoms and the stent had occluded.The physician re-ballooned the stent and performed a mechanical thrombectomy.Additional information indicated that the patient's symptoms were resolving.At this time, it is unknown if the reported event is related to medication/patient response (plavix resistance), a procedural issue, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.
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Search Alerts/Recalls
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