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

Model Number	R5-023
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aortic Regurgitation (1716)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not explanted.
Event or Problem Description
A carbomedics reduced aortic valve, r5-021, was implanted on (b)(6) 2014.In 2018, it was reported that the valve was leaking, and re-operation cannot be performed.No other information was provided.
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.As the device remains implanted, no further investigation can be performed.Given the limited event information provided, it is not possible to determine the root cause of the incident, or to confirm that the event is attributable to the device.Should additional information be received in the future, the case will be re-assessed and appropriate investigative action will be taken.

• Brand Name: CARBOMEDICS REDUCED PROSTHETIC HEART VALVE, AORTIC
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 8156871
• Report Number: 3005687633-2018-00225
• Device Sequence Number: 1244459
• Product Code: LWQ
• UDI-Device Identifier: 08022057012777
• UDI-Public: (01)08022057012777(240)R5-021(17)160328
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2019

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: 03/28/2016
• Device Model Number: R5-023
• Device Catalogue Number: R5-021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/17/2019
• 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: Other; Required Intervention
• Patient Age: 53 YR