Model Number H749LVSUS270 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Type
Injury
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Manufacturer Narrative
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Exemption number: e2020001.Quarterly reporting period: q4 2020.Average time to event: 1 day.Device evaluation: under the terms and conditions of the registry, anonymized data was provided.It cannot be determined if these events have been previously reported or if the devices were returned for analysis.However, the events reported were anticipated in nature as defined by the potential adverse events list in the fda-approved instructions for use (ifu).
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Event Description
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This report summarizes 1 serious injury event for a medical problem.Boston scientific received notification of events for the lotus edge valve reported in the (b)(6) registry.The data is collected in order to monitor patient safety and real-world outcomes related to transcatheter valve replacement and repair procedures.Patient events were reported as event terms with no further detailed information.Under the terms and conditions of the (b)(6) registry, data is anonymized before being transmitted to bsc, thus there are significant limitations to bsc's ability to correlate the data to information previously reported.The events are most likely duplicates with potential for non-device related adverse events included.No further information is available to bsc.
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Search Alerts/Recalls
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