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

Model Number CPHV

Device Problem Difficult to Open or Close (2921)

Patient Problems Pneumonia (2011); Septic Shock (2068); Unspecified Kidney or Urinary Problem (4503)

Event Date 06/15/2021

Event Type  Injury  

Event 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.

Manufacturer Narrative

Fields updated: b4, g3, g6, h1, h2, h6.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.Further tests will be performed upon device receipt.The conclusions are not yet available.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• MDR Report Key: 12178564
• MDR Text Key: 261907048
• Report Number: 3005687633-2021-00146
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012753
• UDI-Public: (01)08022057012753(240)M7-033(17)221103
• Combination Product (y/n): N
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention