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

Model Number	R5-032
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition not presently known.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 8368705
• Report Number: 3005687633-2019-00148
• Device Sequence Number: 11167957
• Product Code: LWQ
• UDI-Device Identifier: 08022057012784
• UDI-Public: (01)08022057012784(240)R5-023(17)221231
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention