MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL CARBOMEDICS TOP HAT MECHANICAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	CPHV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device model s5-025 and sn (b)(4) has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.No information on the device disposition is presently available (not returned to the manufacturer after the explant).Based on the available information, it is not possible to establish a definitive root cause for the reported event.However, based on the document review performed, no manufacturing deficiencies were identified.The manufacturer is following up with the site to retrieve additional information on this event.Should an further information be received, the manufacturer will update this reporting activity.
Event or Problem Description
The manufacturer was informed of this event through the device tracking department.Based on the information reported in the patient implant form, a carbomedics top hat valve s5-025 was implanted on (b)(6) 2015.The valve was explanted on (b)(6) 2020 and replaced with a new top hat s5-025.No further information is presently available.No allegation of a device malfunction nor of a serious injury was received from the site regarding this event.
Additional Manufacturer Narrative
Fields updated: b4, f6, f7, f10.The manufacturer updated section f10 with the "health effect - impact code" which is a new field introduced with the new medwatch, and not previously submitted with the intiial report.The remainder of the information previously submitted is unchanged.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 11128356
• Report Number: 1718850-2020-01224
• Device Sequence Number: 13625462
• Product Code: LWQ
• UDI-Device Identifier: 08022057012920
• UDI-Public: (01)08022057012920(240)S5-025(17)190421
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2021
• Report Date (Section F): 12/08/2020

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: 04/21/2019
• Device Model Number: CPHV
• Device Catalogue Number: S5-025
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/08/2021
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/08/2020; 03/08/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 02/13/2021; 03/08/2021
• 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: 67 YR