MAUDE Adverse Event Report: CORCYM S.R.L. CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL; MECHANICAL HEART VALVE PROSTHESIS

Model Number	CPHV
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Codes	Pneumonia (2011); Septic Shock (2068); Unspecified Kidney or Urinary Problem (4503)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, a patient received a carbomedics standard mitral valve.Upon bypass weaning, a mitral valve prosthesis dysfunction was noted as also confirmed on arrival at icu with transesophageal echocardiogram.The patient presented acute prosthesis dysfunction, with a fixed disc, for which a mitral valve replacement was again performed, currently complicated with pneumonic process, acute kidney injury and resolution of septic shock over time with mechanical ventilation.The device was replaced with a biological valve perimount mitral 31.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia 13040 ; IT 13040
• MDR Report Key: 12181512
• Report Number: 1718850-2021-01129
• Device Sequence Number: 1533223
• Product Code: LWQ
• UDI-Device Identifier: 08022057012753
• UDI-Public: (01)08022057012753(240)M7-033(17)221103
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2021

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: 11/03/2022
• Device Model Number: CPHV
• Device Catalogue Number: M7-033
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2021
• 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