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

Model Number EC0404

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

Patient Problem Aortic Insufficiency (1715)

Event Date 03/02/2018

Event Type  Injury  

Manufacturer Narrative

This event is being re-submitted as the original medwatch 3500a form (3010805634-2018-00003 was not properly submitted on 12/6/18 through the electronic submission gateway (esg) portal.Original narrative dated 12/6/18: device not returned for evaluation.Patient recovered with sequelae.

Event Description

Cardioseal material was dilated leading to higher grade insufficiency of the repaired aortic valve.The patient underwent a avr re-operation after less than 2 years.

• Brand Name: CARDIOCEL
• Type of Device: CARDIOVASCULAR PATCH
• Manufacturer (Section D): ADMEDUS REGEN PTY LTD; 26 harris road; malaga, west australia 6090 ; AS 6090
• Manufacturer (Section G): ADMEDUS REGEN PTY LTD; 26 harris road; malaga, west australia 6090 ; AS 6090
• Manufacturer Contact: seona roberts ; 26 harris road; malaga, west australia 6090 ; AS 6090
• MDR Report Key: 9367773
• MDR Text Key: 168054796
• Report Number: 3010805634-2019-00006
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 12/06/2018

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: EC0404
• Device Catalogue Number: C0404
• Device Lot Number: M14019-20-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Age: 47 YR