MAUDE Adverse Event Report: ADMEDUS REGEN PTY LTD CARDIOCEL NEO; INTRACARDIAC PATCH

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.

• Brand Name: CARDIOCEL NEO
• Type of Device: INTRACARDIAC PATCH
• Manufacturer (Section D): ADMEDUS REGEN PTY LTD; 26 harris road; malaga, western australia 6080 ; AS 6080
• Manufacturer (Section G): ADMEDUS REGEN PTY LTD; 26 harris road; malaga, western australia 6080 ; AS 6080
• Manufacturer Contact: jim chapman ; 860 blue gentien road; suite 340; eagan, MN 55121 ; 6514930606
• MDR Report Key: 15739054
• MDR Text Key: 303145993
• Report Number: 3012664855-2022-00007
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2023
• Device Catalogue Number: UC0508N
• Device Lot Number: M20028-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 19 MO
• Patient Sex: Female
• Patient Weight: 8 KG