Catalog Number UC0508N |
Device Problem
Insufficient Information (3190)
|
Patient Problem
Stenosis (2263)
|
Event Date 05/25/2021 |
Event Type
Injury
|
Event Description
|
Pulmonary atresia with vsd, ductal stent placed in neonatal period then (b)(6) 2021 complete repair with vsd closure, transannular patch (cardiocel) and lpa plasty (cardiocel).Lpa occluded, requiring stent placement.Then developed significant rv outflow tract obstruction, redo operation in (b)(6) 2022 with patch augmentation of prior transannular patch.Endothelialized surface inside the transannular patch was very thickened, leading to a focal stenosis where the pulmonary annulus would have been (nearly circumferential cardiocel here).Tried to "thin out" the native pulmonary annulus but was actually very thin, thickening was all the patch material.Revised with an autologous pericardial patch, leaving some cardiocel at the distal pa where it appeared visually widely patent.On followup, the area where cardiocel remained in the distal main pa is now severely stenotic and planning for cath to attempt to balloon it.Echo (b)(6) 21 prompted decision to reoperate, delayed multiple times due to uri and uti and then redo sternotomy in (b)(6) 2022.Ct (b)(6) 2022 demonstrated residual stenosis at distal mpa, the one area with residual cardiocel patch material.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Pulmonary atresia with vsd, ductal stent placed in neonatal period then (b)(6) 2021 complete repair with vsd closure, transannular patch (cardiocel) and lpa plasty (cardiocel).Lpa occluded, requiring stent placement.Then developed significant rv outflow tract obstruction, redo operation in (b)(6) 2022 with patch augmentation of prior transannular patch.Endothelialized surface inside the transannular patch was very thickened, leading to a focal stenosis where the pulmonary annulus would have been (nearly circumferential cardiocel here).Tried to "thin out" the native pulmonary annulus but was actually very thin, thickening was all the patch material.Revised with an autologous pericardial patch, leaving some cardiocel at the distal pa where it appeared visually widely patent.On followup, the area where cardiocel remained in the distal main pa is now severely stenotic and planning for cath to attempt to balloon it.Echo (b)(6) 2021 prompted decision to reoperate, delayed multiple times due to uri and uti and then redo sternotomy in (b)(6) 2022.Ct (b)(6) 2022 demonstrated residual stenosis at distal mpa, the one area with residual cardiocel patch material.
|
|
Search Alerts/Recalls
|
|