Model Number SR-0940-CS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 05/10/2022 |
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; the cause of the post-operative complication is unknown, therefore, the complaint will be reported out of abundance of caution.Complaints will continue to be reviewed and monitored for trends.A supplemental mdr will be submitted if additional information is received.
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Event Description
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It was reported that two hours after the completion of a transcarotid artery revascularization (tcar) procedure, the patient's implanted stent had thrombosed.The physician elected to perform a balloon and aspiration thrombectomy to resolve the thrombosis, and the patient was placed on ticagrelor/brilinta.At this time, it is unknown if the reported failure is related to procedural issues, patient resistance to dual antiplatelet therapy (dapt) medication, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.
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Event Description
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It was reported that two hours after the completion of a transcarotid artery revascularization (tcar) procedure, the patient's implanted stent had thrombosed.The physician elected to perform a balloon and aspiration thrombectomy to resolve the thrombosis, and the patient was placed on ticagrelor/brilinta.At this time, it is unknown if the reported failure is related to procedural issues, patient resistance to dual antiplatelet therapy (dapt) medication, 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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Additional/updated information can be found in the following fields: b4: date of this report.D4: additional device information.G6: type of report.H2: if follow up, what type? a follow-up mdr is being submitted to reflect the correct unique device identifier under section d4: unique identifier (udi) #.
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Search Alerts/Recalls
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