Catalog Number UC0508N |
Device Problem
Insufficient Information (3190)
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Patient Problem
Stenosis (2263)
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Event Date 05/19/2020 |
Event Type
Injury
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Manufacturer Narrative
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Review of batch record did not identify any deviations or errors.Investigation and interviews with clinicians have been scheduled.Adverse events associated with bioprosthetic pericardial patches that have been reported in the literature, have included flow obstruction.
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Event Description
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Scimitar syndrome, baffle of right pulmonary vein to the la with bovine pericardium in 2017.Re-operation in 2020 using cardiocel.Cadiocel patch occluded requiring repeat surgery in 2020 (re-implantation directly to the la).
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Manufacturer Narrative
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Review of batch record did not identify any deviations or errors.Investigation completed and interviews with clinicians have been performed.The events occurred in 7 patients out of 140 treated with cardiocel.A call with physicians occurred to discuss the procedure and their findings.It was noted the events happened in cases of pa repair.Batch record review determined that all products met acceptance criteria.There were no manufacturing changes during this time period to suggest a change on the product.While anteris continues to monitor, it appears at this time the event to be unlikely related to the product but rather associated with the complex intervention and challenges of vascular reconstruction in these young patients.
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Event Description
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Scimitar syndrome, baffle of right pulmonary vein to the la with bovine pericardium in 2017.Re-operation in 2020 using cardiocel.Cadiocel patch occluded requiring repeat surgery in 2020 (re-implantation directly to the la).
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Search Alerts/Recalls
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