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	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On 09 oct 2020, a carbomedics top hat s5-025 was intended for an aortic valve replacement procedure.After the box of the valve was opened, the valve was checked and no deficiencies were identified, so the valve was implanted.After finishing the suture of the valve, the valve was tested with the dedicated accessories provided, but the leaflet rotation was found not so smooth.Since a malfunction in the device was suspected, the valve was immediately explanted and replaced a new valve with the same model s5-025.The surgery was completed successfully with the new s5-025.No impact for the patient was reported, who recovered and been discharged from hospital.
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 device was reportedly available for investigation, but not yet returned to the manufacturer.Based on the available information, it is not possible to draw a definitive conclusion on the reported event.However, from the document review performed, no manufacturing deficits were identified.As reported, no device abnormalities were identified upon valve opening, thus it is not possible to confirm whether the reported difficulties refer to an intraoperative procedural difficulty or rather, whether a device problem occurred.The manufacturer will perform further investigations on the device once returned and update the reporting activity accordingly.
Additional Manufacturer Narrative
The manufacturer has corrected section h3.The device was initially reportedly as available for investigation, but was not yet returned to the manufacturer up to date (189 days since the initial notification of the event).As such, no investigation on the device has been possible.There is no change to the rest of information or to the conclusion previously provided for this event.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino; saluggia, vercelli
• MDR Report Key: 11572595
• Report Number: 3005687633-2021-00106
• Device Sequence Number: 14519538
• Product Code: LWQ
• UDI-Device Identifier: 08022057012920
• UDI-Public: (01)08022057012920(240)S5-025(17)211220
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: 12/20/2021
• Device Model Number: CPHV
• Device Catalogue Number: S5-025
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/10/2021
• 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