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

Model Number	CPHV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device model f7-027 and sn (b)(4) 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 was not returned to the manufacturer (not explanted), no further investigation is possible at this time.Based on the available information, it is not possible to establish a definitive root cause for the reported event.However, from the document review performed, no manufacturing deficiencies were identified.Since it is reported that the device model f7-027 was checked at the end of the surgery and during the emergency ultrasound, and no anomalies were identified, there is no evidence suggesting a device malfunction which could have contributed to the event.Ultimately, since no further information nor medical judgment on the event was provided, the root cause remains unknown at this time.Should the manufacturer receive additional information in the future, a follow up report will be provided.
Event or Problem Description
On (b)(6) 2021 the patient underwent aortic and mitral valve replacement with corcym devices due to lesions on both valves.The patient received an optiform size 27 in mitral position and a top hat size 21 in aortic position.The devices were safely implanted during the surgery and patient did well during surgery.There was no abnormality or malfunction noted on the valve during surgery.The valves were tested after implantation and confirmed the position and opening and closing function was good.After the operation, the heart rate and blood pressure were stable, so the patient was then transferred to icu for observation.Two hours post-operation, the patient had a sudden loss of blood pressure (blood pressure 0), but the heartbeat remained.Then, the patient died.The emergency ultrasound showed inadequate opening and closing motion for s5 valve.Since no further investigation on the patient was possible, the site could not assess the relationship between the devices and the event, nor if the devices malfunctioned or not.No further information is available at this time.

• Brand Name: OPTIFORM PROSTHETIC MITRAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 12598202
• Report Number: 3005687633-2021-00159
• Device Sequence Number: 3586062
• Product Code: LWQ
• UDI-Device Identifier: 08022057012852
• UDI-Public: (01)08022057012852(240)F7-027(17)251018
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P900060/S019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 10/07/2021

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: 10/18/2025
• Device Model Number: CPHV
• Device Catalogue Number: F7-027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 10/08/2021
• 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: Death
• Patient Age: 67 YR