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

Model Number C0404

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis (2263)

Event Date 07/03/2015

Event Type  Injury  

Manufacturer Narrative

This event is being re-submitted as the original medwatch 3500a form (3010805634-2018-00004) was not properly submitted on 12/20/2018 through the electronic submission gateway (esg) portal.Original narrative dated 12/20/2018: this event is being conservatively reported as reintervention in chd is an expected event in 12-15% of congenital cardiac patients according to peer reviewed clinical literature.The device was replaced with another cardiocel device.Due to lack of information, this event is not currently assessable.No additional actions required at this time.

Event Description

Increased obstruction in rvot, patch resection performed.A new patch was implanted and patient recovered with sequelae.

• Brand Name: CARDIOCEL
• Type of Device: CARDIOVASCULAR PATCH
• Manufacturer (Section D): ADMEDUS REGEN PTY LTD; 26 harris road; malaga, 6090 ; AS 6090
• Manufacturer (Section G): ADMEDUS REGEN PTY LTD; 26 harris road; malaga, 6090 ; AS 6090
• Manufacturer Contact: seona roberts ; 26 harris road; malaga, west australia 6090 ; AS 6090
• MDR Report Key: 9367809
• MDR Text Key: 167777854
• Report Number: 3010805634-2019-00002
• 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: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C0404
• Device Catalogue Number: C0404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 MO