Catalog Number UC0404N |
Device Problem
Insufficient Information (3190)
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Patient Problem
Stenosis (2263)
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Event Date 04/13/2020 |
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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Re-operation for occluded lpa from prior tof repair with left pulmonary arterioplasty.Cardiocel used to augment lpa.Re-stenosed the lpa within 2 months (severe, near occlusion) and required balloon and stent in cath lab on (b)(6) 2022 with multiple procedures to up-size the stent for somatic growth ((b)(6) 2022, (b)(6) 2021.).
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Event Description
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Re-operation for occluded lpa from prior to f repair with left pulmonary arterioplasty.Cardiocel used to augment lpa.Restenosed the lpa within 2 months (severe, near occlusion) and required balloon and stent in cath lab on (b)(6) 2020 with multiple procedures to up-size the stent for somatic growth ((b)(6) 2020, (b)(6) 2021).
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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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