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
Additional Manufacturer Narrative
Device was not returned, unknown disposition.
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.
Additional Manufacturer Narrative
Sections update: b4, g3,g6,h1,h2, h3, h6, h10.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.Since the device has not been return no further investigation can be completed.Based on the available information, it is not possible to establish a definitive root cause for the reported event.However, per the document review performed, no manufacturing deficiencies were identified. should further information be provided a follow up report will be sent.

• Brand Name: STANDARD SIZE 31 MITRAL
• Common Device Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL
• Manufacturer (Section D): CORCYM CANADA CORP; 5005 north frasier way; burnaby, bc
• MDR Report Key: 12215223
• Report Number: 3005687633-2021-00147
• Device Sequence Number: 4136487
• Product Code: LWQ
• UDI-Device Identifier: 08022057012746
• UDI-Public: (01)08022057012746(240)M7-031(17)240208
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 09/13/2021
• 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