Catalog Number UC0508N |
Device Problem
Insufficient Information (3190)
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Patient Problem
Stenosis (2263)
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Event Date 04/22/2020 |
Event Type
Injury
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Event Description
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Partial anomalous pulmonary venous return of the right-sided veins to the ivc (scimitar syndrome); intra-atrial baffle in (b)(6) 2020 with subsequent occlusion.Tissue thickened around patch.Revision in 2022 with re-implantation of vein which was small and scarred; subsequently re-occluded, unable to be recanalized with a cath, and awaiting decision on next steps.
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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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Partial anomalous pulmonary venous return of the right-sided veins to the ivc (scimitar syndrome); intra-atrial baffle in april 2020 with subsequent occlusion.Tissue thickened around patch.Revision in 2022 with re-implantation of vein which was small and scarred; subsequently re-occluded, unable to be recanalized with a cath, and awaiting decision on next steps.
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Manufacturer Narrative
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Review of batch record did not identify any deviations or errors.Investigation has been 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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Search Alerts/Recalls
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