MAUDE Adverse Event Report: CORCYM CANADA CORP. STANDARD SIZE 31 MITRAL; CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL

Model Number	M7-031
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Based on the information provided on (b)(6) 2021 a carbomedics 31 mm mitral valve was implanted and explanted on the same day.No further information has been provided.

• Brand Name: STANDARD SIZE 31 MITRAL
• Common Device Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 12216198
• Report Number: 1718850-2021-01133
• Device Sequence Number: 4173389
• Product Code: LWQ
• UDI-Device Identifier: 08022057012746
• UDI-Public: (01)08022057012746(240)M7-031(17)240208
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/23/2021
• Report Date (Section F): 06/25/2021

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: 02/08/2024
• Device Model Number: M7-031
• Device Catalogue Number: M7-031
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2021
• 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: Other
• Patient Age: 59 YR