Model Number 31MJ-501 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Death (1802)
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Event Date 12/13/2019 |
Event Type
Death
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Manufacturer Narrative
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Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Event Description
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On (b)(6) 2019, a 31mm masters valve was implanted.3 days post implant on (b)(6) 2019, the patient expired due to unknown causes.Additional information was requested but cannot be provided.
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Manufacturer Narrative
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An event of patient death due to unknown causes 3 days after implant was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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