Model Number SR-200-NPS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Muscle Weakness (1967); Ischemia Stroke (4418)
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Event Date 01/11/2024 |
Event Type
Injury
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Event Description
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It was reported that after a left transcarotid artery revascularization (tcar) procedure, the patient experienced right arm weakness and had an ischemic (embolic) stroke.There was no additional intervention performed and the patient's symptoms completely resolved within 48 hours.At this time, it is unknown if the reported failure is related to procedural issues,medication non-compliance or resistance, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.
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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 manufacturing records for this device was completed and no issues were identified that could have led to the adverse event reported.At this time, it is unknown if the reported failure is related to procedural issues, medication non-compliance or resistance, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.Silk road medical will continue to monitor for occurrences of similar events.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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Search Alerts/Recalls
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