MAUDE Adverse Event Report: CORCYM S.R.L. CARBOMEDICS TOP HAT MECHANICAL HEART VALVE; MECHANICAL HEART VALE PROSTHESIS

Model Number CPHV

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2021

Event Type  Death  

Manufacturer Narrative

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 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.It is reported that the device model s5 was checked during the emergency ultrasound that showed an inadequate opening motion.Since however the patient had a sudden blood loss, it is not possible to judge whether the inadequate opening was a cause or a result of the reported event.At the end of the surgical procedure, a good valve functionality was detected.Given that no further investigation on the device was possible, and since no medical judgment was received on the event, the root cause remains unknown at this time.

Event 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 (ref (b)(4)) 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: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Type of Device: MECHANICAL HEART VALE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 12598300
• MDR Text Key: 275422412
• Report Number: 3019892983-2021-01020
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012906
• UDI-Public: (01)08022057012906(240)S5-021(17)260321
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2021,10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CPHV
• Device Catalogue Number: S5-021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/08/2021
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2021
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR