MAUDE Adverse Event Report: ANTERIS AUS OPERATIONS PTY LTD CARDIOCEL; INTRA CARDIAC PATCH OR PLEGET

Model Number	UC0404
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Anteris received a report from teh distributor that a physician reported that the cardiocel patch had thickened (described as "peel) after a vessel reconstruction resulting in thickening and narrowing of the vessel repair.
Additional Manufacturer Narrative
The age of the patient is unknown.The patient presented with stenosis of the vessal reconstructon.Surgical intervention was performed.The device remains implanted.Review of manufacturing records does not show deviations to the manufacturing process or errors or deviations.No changes were made to the manufacturing process to suggest a change in the product.It appears the event was unlikely related to teh device.Flow obstruction following surgery is a potential adverse event listed in the instructions for use.

• Brand Name: CARDIOCEL
• Common Device Name: INTRA CARDIAC PATCH OR PLEGET
• Manufacturer (Section D): ANTERIS AUS OPERATIONS PTY LTD; 26 harris road; malaga, western australia 6080 ; AS 6080
• Manufacturer (Section G): ANTERIS AUS OPERATIONS PTY LTD; 26 harris road; malaga, western australia 6090 ; AS 6090
• Manufacturer Contact: jim chapman ; 806 blue gentien road; suite 340; eagan, MN 55121-1575 ; 6128955271
• MDR Report Key: 20312785
• Report Number: 3012994855-2024-00006
• Device Sequence Number: 20834646
• Product Code: PSQ
• UDI-Device Identifier: 09348992000594
• UDI-Public: 09348992000594
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/27/2022
• Device Model Number: UC0404
• Device Catalogue Number: C0404
• Device Lot Number: M19040-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 4 YR
• Patient Sex: Prefer Not To Disclose