MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS REDUCED AORTIC VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number R5-032

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

Device disposition not presently known.

Event Description

A carbomedics reduced aortic valve was reportedly "used" but not implanted.The event is being reported in a conservative manner due to unknown relationship to the device and unknown patient impact.

Event Description

A carbomedics reduced r5-023 was "not implanted" in a patient.The site confirmed that the package was opened, but that it was not used and was thrown away.There was no patient involvement, and no event has been identified.

Manufacturer Narrative

It was reported that the device was discarded without being implanted.There was no patient impact or identified device issue.The event is deemed not valve related, and no further investigation is required.

• Brand Name: CARBOMEDICS REDUCED AORTIC VALVE
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 8368705
• MDR Text Key: 137114318
• Report Number: 3005687633-2019-00148
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012784
• UDI-Public: (01)08022057012784(240)R5-023(17)221231
• Combination Product (y/n): N
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: R5-032
• Device Catalogue Number: R5-032
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention