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	02/11/2020
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 top hat mechanical valve s5-027 was implanted on (b)(6) 2020 and explanted on the same day.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
Fields updated: b4, b5, f6, f7.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 attempted to retrieve additional information on this event.However, no further details has been received to date on this event and on the device disposition after the explant.Based on the limited information available, it is not possible to draw a definitive conclusion on the reported event.However, from the document review performed, no manufacturing deficits were identified.Should any information be received at a later stage, the manufacturer will re-assess the event and provide an update to this reporting activity as applicable.

• 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: 10805576
• Report Number: 1718850-2020-01190
• Device Sequence Number: 19650156
• Product Code: LWQ
• UDI-Device Identifier: 08022057012937
• UDI-Public: (01)08022057012937(240)S5-027(17)220415
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2020
• Report Date (Section F): 10/09/2020

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: 04/15/2022
• Device Model Number: CPHV
• Device Catalogue Number: S5-027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/03/2020
• Device Age: 33 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/30/2020
• 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: 64 YR