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

Model Number CPHV

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/24/2021

Event Type  Death  

Manufacturer Narrative

Unknown disposition.

Event Description

The manufacturer was informed of this event through the device tracking department.Based on the information reported in the patient implant form, a carbomedics top hat valve s5-019 was implanted on (b)(6) 2021.The form also indicated that the patient passed away on the same day.As reported, the patient received multiple valve replacements.No further information is presently available.

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 (disposition unknown) no further investigations is possible at this time.The manufacturer attempted to retrieve additional information from the hospital but no further information has been received to date.Based on the information available, 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.Furthermore, the manufacturer did not receive any allegation of a device malfunctions nor of adverse event for this device (event notified from the patient registration form received).Ultimately, the root cause remains unknown.Should any further information be received in the future, the manufacturer will provide a follow up report as applicable.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 12917745
• MDR Text Key: 281606966
• Report Number: 3005687633-2021-00166
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012890
• UDI-Public: (01)08022057012890(240)S5-019(17)240531
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• 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: S5-019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 48 YR
• Patient Sex: Male