Device Problem
Folded (2630)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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Due to limited information, this event is being reported in a conservative manner.The manufacturer is currently in the process of receiving further information from the physician on this event.Manufacturing site is unknown as the serial number is not yet known.Livanova (b)(4) corp is listed for this report for the manufacturing site but could also be the sister site, (b)(4).Device manufacture date and date of expiry is unknown as sn# is not yet known.Not yet determined if device available.
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Event Description
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The manufacturer was notified on (b)(6) 2017 that a perceval valve experienced stent folding, no further information has been provided at present.Livanova (b)(4) corp is in the process of gaining further information from the physician on this event.
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Manufacturer Narrative
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Multiple attempts have been made by the manufacturer in contacting the physician to gather further information on this event.No further information has been provided.The device is not available for return or analysis, nor is the serial number known.No further investigation can be completed at this time.Manufacturing site is unknown as the serial number is not known.Livanova (b)(4) corp is listed for this report for the manufacturing site but could also be the sister site, (b)(4).Device manufacture date and date of expiry is unknown as sn # is not known.
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Search Alerts/Recalls
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