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

Model Number EC0404N

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Stenosis (2263)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

Initial report, device not returned for inspection.Review of batch record did not identify any deviations or errors.

Event Description

This is an initial report.The following report was provided to anteris through the distributor lemaitre vascular on 07/20/2023.This incident occurred at a hospital in (b)(6).Per the physician's narrative, the patch was implanted on (b)(6) 2022 as a transannular patch in a fallot patient with pulmonary atresia and previous palliation with ductal stent.The native pa was diminutive and the reconstruction was in great part at expense of the patch (the new pa was in great part made from cardiocel).The patient developed estenosis of left pulmonary artery, treated in an occasion by cath lab procedure.In a second occasion the interventionism failed.The patient was presented for redo surgery, and in the or ((b)(6) 2023) we observed a huge reaction to the patch, which was narrowing the pulmonary artery.There was a thick neointima, easily separating from the original patch.It was sent to histology.Histology: fibroconnective tissue, with histiocitic cellularity, fibrin and inflammatory infiltration, and reactive fibroblasts.

Manufacturer Narrative

Review of manufacturing record for the lot in question did not show any deviations to the manufacturing process or errors.There were no manufacturing changes during this time period to suggest a change on the product.No additional information was provided by the initial reporter.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 tetralogy of fallot patients.Stenosis of repair causing obstruction of flow through repaired vessel is listed as a potential hazard.The potential cause is intimal hyperplasia caused by vessel injury during reconstruction or repair.Flow obstruction is also listed as a potential adverse event in the product ifu.

Event Description

This is an final report.The following report was provided to anteris through the distributor lemaitre vascular on 07/20/2023.This incident occurred at a hospital in madrid, spain.Per the physician's narrative, "the patch was implanted on (b)(6) 2022 as a transannular patch in a fallot patient with pulmonary atresia and previous palliation with ductal stent.The native pa was diminutive and the reconstruction was in great part at expense of the patch (the new pa was in great part made from cardiocel).The patient developed estenosis of left pulmonary artery, treated in an occasion by cath lab procedure.In a second occasion the interventionism failed.The patient was presented for redo surgery, and in the operating room ((b)(6) 2023) we observed a huge reaction to the patch, which was narrowing the pulmonary artery.There was a thick neointima, easily separating from the original patch.It was sent to histology.Histology: fibroconnective tissue, with histiocitic cellularity, fibrin and inflammatory infiltration, and reactive fibroblasts.".

• Brand Name: CARDIOCEL NEO
• Type of Device: INTRACARDIAC PATCH OR PLEDGET
• 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 ; 806 blue gentien road; suite 340; eagan, MN 55121 ; 6514930606
• MDR Report Key: 17494856
• MDR Text Key: 320765990
• Report Number: 3012664855-2023-00001
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K130872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: EC0404N
• Device Lot Number: M20035-0191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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; Required Intervention; Hospitalization
• Patient Age: 3 MO
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Hispanic