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

Device Problem Structural Problem (2506)

Patient Problem Stenosis (2263)

Event Type  Injury  

Event Description

Peel formation due to excessive neointima formation, excessive adventitial response and structural disruption of the patch.

• Brand Name: CARDIOCEL
• 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 6090 ; AS 6090
• Manufacturer Contact: janel hurtado ; 860 blue gentian road; suite 340; eagan, MN 55121 ; 6514930606
• MDR Report Key: 10782286
• MDR Text Key: 214515515
• Report Number: 3012664855-2020-00006
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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