CRYOLIFE, INC. PULMONARY VALVE & CONDUIT SG; HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT
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Model Number SGPV00 |
Device Problems
Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Congenital Defect/Deformity (1782); Pulmonary Valve Stenosis (2024)
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Event Date 02/14/2019 |
Event Type
Injury
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Manufacturer Narrative
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This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
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Event Description
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According to the implant summary card, previously implanted cryolife tissue was explanted on (b)(6) 2019.Additional information received from the cryolife rep, indicates that a cryolife sgpv00 serial number (sn): (b)(4) was implanted on (b)(6) 2015.Additional information from karen krusinski, rn cardiac or team leader, relayed that the sgpv00 serial number (b)(4) was explanted on (b)(6) 2019 due to stenosis rv-pa conduit.The pre-op diagnosis for the procedure was stenosis rv-pa conduit, aortic atresia, vsd, s/p norwood, s/p rastelli.The procedure performed was pulmonary valve replacement.The patient was discharged home on (b)(6) 2019.No additional information.
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Event Description
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According to the implant summary card, previously implanted cryolife tissue was explanted on (b)(6) 2019.Additional information received from the cryolife rep, indicates that a cryolife sgpv00 serial number (sn): (b)(6) was implanted on (b)(6) 2015.Additional information from the rn cardiac or team leader, relayed that the sgpv00 serial number (b)(6) was explanted on (b)(6) 2019 due to stenosis rv-pa conduit.The pre-op diagnosis for the procedure was stenosis rv-pa conduit, aortic atresia, vsd, s/p norwood, s/p rastelli.The procedure performed was pulmonary valve replacement.The patient was discharged home on (b)(6) 2019.No additional information.
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Manufacturer Narrative
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This investigation is currently ongoing.Any additional information will be provided in the follow-up report.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
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Manufacturer Narrative
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A root cause for the reported event is conduit stenosis.This is a known potential complication in children undergoing the yasui procedure previously reported in the literature.There is no evidence to suggest that there was an inherent defect in the graft prior to implant.All attributes noted during inspection of the allograft were documented appropriately and the allograft met specifications.A review of training records indicates that the technicians associated with the processing of this allograft were appropriately trained for the tasks performed.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
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Event Description
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According to the implant summary card, previously implanted cryolife tissue was explanted on (b)(6) 2019.Additional information received from the cryolife rep, indicates that a cryolife sgpv00 serial number (sn): (b)(4) was implanted on (b)(6) 2015.Additional information from (b)(6), rn cardiac or team leader, relayed that the sgpv00 serial number (b)(4) was explanted on (b)(6) 2019 due to stenosis rv-pa conduit.The pre-op diagnosis for the procedure was stenosis rv-pa conduit, aortic atresia, vsd, s/p norwood, s/p rastelli.The procedure performed was pulmonary valve replacement.The patient was discharged home on (b)(6) 2019.
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Search Alerts/Recalls
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