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

Model Number	R5-021
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device location not presently known.
Event or Problem Description
On (b)(6) 2015, the patient received a carbomedics reduced aortic valve r5-021, sn # (b)(4) as part of the native aortic valve replacement, on (b)(6) 2018, the patient was operated again to have the device explanted and replaced with another carbomedics reduced aortic valve r5-021 ((b)(4)).
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.Since the device was not returned to the manufacturer, further investigation was not possible.Several attempts have been made to contact the site and gather additional information on the event.Despite the follow-ups, the site did not provide any feedback on the event.Based on the information available to date, it is not possible to establish the root cause of the explant of the device.The case will be re-assessed if new information is received.Device location not presently known.
Event or Problem Description
On (b)(6) 2015, the patient received a carbomedics reduced aortic valve r5-021, sn # (b)(4) as part of the native aortic valve replacement, on (b)(6) 2018, the patient was operated again to have the device explanted and replaced with another carbomedics reduced aortic valve r5-021 (b)(4).No other information was provided up to this date.

• 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, vercelli
• MDR Report Key: 8066791
• Report Number: 3005687633-2018-00210
• Device Sequence Number: 11367246
• Product Code: LWQ
• UDI-Device Identifier: 08022057012777
• UDI-Public: (01)08022057012777(240)R5-021(17)200216
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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: 02/16/2020
• Device Model Number: R5-021
• Device Catalogue Number: R5-021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/12/2018
• 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
• Patient Age: 65 YR