Model Number PVS21 |
Device Problems
Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Information (3190)
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Event Date 12/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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Due to the limited information available on the reason for the re-intervention, on the patient's impact and on the relationship with the device, the event is being reported in a conservative manner.The manufacturer is following up to obtain further information.Device not explanted.
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Event Description
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The manufacturer was informed that a patient is being monitored for a potential tavi procedure.The patient received a perceval pvs21 in aortic position.No other information is currently available.
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Manufacturer Narrative
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Despite the attempts to retrieve further information on the event, no additional data has been received to date, except for the device implant date.Since the serial number was not provided and the device remains implanted in the patient, no further investigation can be performed.If new information is received, the case will be re-assessed and appropriate investigative action will be taken.
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Event Description
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The manufacturer was informed that a patient is being monitored for a potential tavi procedure.The patient received a perceval pvs21 in aortic position in (b)(6) 2014.No other information is currently available.
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Search Alerts/Recalls
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