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.
Additional 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.
Additional Manufacturer Narrative
Fields updated: b4, d9, g3, g6, h1, h2, h6.The device was not returned despite follow-ups; thus, no further investigation on the explanted device could be performed.Based on the available information, the root cause of the event could not be established.Based on the information received, the standard mitral valve size 33 was explanted and perimount valve size 31 was implanted instead.As such, the cause of the reported event could possibly be related to missizing but this cannot ultimately be confirmed since the device was not returned to the manufacturer for further investigation.However, no deficits were noted during the production records review.Should further information and/or the device be received in the future, the manufacturer will re-visit the case and take further actions as applicable.

• 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, vercelli
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 12178564
• Report Number: 3005687633-2021-00146
• Device Sequence Number: 1621881
• Product Code: LWQ
• UDI-Device Identifier: 08022057012753
• UDI-Public: (01)08022057012753(240)M7-033(17)221103
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 08/05/2021; 10/29/2024
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 09/03/2021; 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown