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 06/03/2019

Event Type  Injury  

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 and formation of clinically significant fibrous tissue.

Event Description

Tof repair with valve-sparing approach and cardiocel patch to infundibulum and main pa.6 months later required redo sternotomy with resection of right ventricular outflow tract, muscle bundles an transannular patch.Significant fibrous tissue on the underside of the patch with extension superiorly just proximal to the pulmonary valve annnulus.Echo with increased gradient across subpulmonary region.

Event Description

Tof repair with valve-sparing approach and cardiocel patch to infundibulum and main pa.6 months later required redo sternotomy with resection of right ventricular outflow tract, muscle bundles an transannular patch.Significant fibrous tissue on the underside of the patch with extension superiorly just proximal to the pulmonary valve annnulus.Echo with increased gradient across subpulmonary region.

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.

• 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: 15738248
• MDR Text Key: 303139398
• Report Number: 3012664855-2022-00003
• 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: 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: 06/21/2020
• Device Catalogue Number: UC0508N
• Device Lot Number: M18018-01
• 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: 06/21/2018
• Is the Device Single Use?: Yes
• 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: 3 YR
• Patient Sex: Male
• Patient Weight: 13 KG