MAUDE Adverse Event Report: CORCYM S.R.L. CARBOMEDICS REDUCED AORTIC VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	R5-025
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer became aware through device tracking information that (b)(6) 2018, a carbomedics reduced aortic mechanical heart valve r5-025 was implanted and then explanted intra-operatively.No allegation of device dysfunction nor patient injury has been received from the healthcare facility.No further information is available at this time.
Additional Manufacturer Narrative
The manufacturing and material records for the device involved in this event, as they pertain to the reported issue, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this prosthesis satisfied all required material, visual, and performance standards at the time of manufacture and release.The manufacturer is following up with the healthcare facility to retrieve additional information on the event and the device involved.A follow up report will be submitted upon receipt of new information.
Event or Problem Description
The manufacturer became aware through device tracking information that on 29 jan 2018, a carbomedics reduced aortic mechanical heart valve r5-025 was implanted and then explanted intra-operatively.As further reported, reason for explant was that the device didn't position well.It was confirmed that there was no device malfunction identified and no added time as a result of the event.Furthermore, the manufacturer was informed that the decision to implant a bioprosthesis was taken during the surgery and the carbomedics valve was replaced with a sutured pericardial valve from a different manufacturer (edwards lifesciences 25mm 2800tfx).Reportedly, the patient was stable throughout the surgery, which was completed without complications and a good outcome.
Additional Manufacturer Narrative
Since the device was not returned for analysis, the manufacturer could not perform further investigation on the explanted prosthesis.Although a direct investigation of the involved prosthesis could not be conducted, the manufacturer received confirmation that no device malfunction was experienced or observed.Additionally, there were no complaints regarding positioning difficulties potentially related to the device's usability.It should be noted that the decision to implant a bioprosthesis instead of the carbomedics mechanical valve was made intra-operatively.Therefore, it cannot be excluded that patient-specific factors evaluated during surgery may have contributed to the reported intra-operative explant.Furthermore, an analysis of production records confirmed that the involved device met all required material, visual, and performance standards at the time of manufacture and release.Based on these considerations, it can be concluded that the cause of the reported event is reasonably due to non-device-related factors.

• Brand Name: CARBOMEDICS REDUCED AORTIC VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vc
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 20482308
• Report Number: 3005687633-2024-00118
• Device Sequence Number: 17170242
• Product Code: LWQ
• UDI-Device Identifier: 08022057012791
• UDI-Public: (01)08022057012791(240)R5-025(17)220619
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: 06/19/2022
• Device Model Number: R5-025
• Device Catalogue Number: R5-025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2017
• 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 Age: 60 YR
• Patient Sex: Unknown