MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL CARBOMEDICS REDUCED AORTIC VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	R5-021
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified of an event involving broken or detached valve leaflets during an attempt to implant a carbomedics reduced aortic valve r5-021 on (b)(6) 2020.No other details are available at this time.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.The manufacturer made several attempts to follow-up for further information related to the specific event details and no further information was received.At this time since information regarding the device is not available no further investigations can be performed.The case will be closed at this time as no further investigation is possible.However, should additional information be provided, the manufacturer will re-assess the event and take further investigative action as applicable.The root cause is thus deemed to be cause not established.

• Brand Name: CARBOMEDICS REDUCED AORTIC VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 10423726
• Report Number: 3005687633-2020-00131
• Device Sequence Number: 2617941
• Product Code: LWQ
• UDI-Device Identifier: 08022057012777
• UDI-Public: (01)08022057012777(240)R5-021(17)230318
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2020

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: 03/18/2023
• Device Model Number: R5-021
• Device Catalogue Number: R5-021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 11/27/2020
• 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