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

Model Number	R5-019
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed on this event through the device tracking department.Based on the information reported on the patient implant form, a carbomedics reduced mechanical valve r5-019 was implanted on (b)(6) 2014 and explanted on (b)(6) 2020.No further information is presently available.No indication of a device malfunction nor serious injury was received from the site regarding this event.
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 on the event and on the device disposition, however, at this time no further information has been received.Based on the available information, it is not possible to draw a definitive conclusion to the reported event.However, from the document review performed, no manufacturing deficits were identified.At this time because no further information is available and the device is not available for analysis the root cause cannot be established.Should further information be received, the manufacturer will reassess the investigation and provide an update to this reporting activity.

• 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: 10805552
• Report Number: 1718850-2020-01189
• Device Sequence Number: 14269626
• Product Code: LWQ
• UDI-Device Identifier: 08022057012760
• UDI-Public: (01)08022057012760(240)R5-019(17)181210
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2020
• Report Date (Section F): 10/08/2020

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: 12/10/2018
• Device Model Number: R5-019
• Device Catalogue Number: R5-019
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/27/2020
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 11/06/2020
• 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
• Patient Age: 41 YR