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 Low Blood Pressure/ Hypotension (1914)

Event Date 04/18/2023

Event Type  Death  

Manufacturer Narrative

A complete manufacturing and material records review for the carbomedics top hat mechanical valve, model #s5-021 s/n #(b)(6) 2023, 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 minimal information was shared with the manufacturer and the device was not returned for analysis, a definitive root cause of the reported event cannot be established.However, from the document review performed, no manufacturing deficiencies were identified.The manufacturer has been informed that no further information will be shared by the site.The manufacturer will provide a follow up report in case any additional information is received.H3 other text : unknown disposition.

Event Description

The manufacturer was informed that on (b)(6) 2023 a 51 year old patient underwent avr with carbomedics top hat supra-annular aortic prosthesis size 21.The surgical procedure was successfully completed.On first post-operative day, the patient experienced a sudden decrease in blood pressure and heart rate couldn't be measured.Ultimately, the patient passed away.No information is available to the manufacturer regarding patient clinical history and risk factors, details on surgical procedure (e.G.If concomitant procedures were performed).No data are available to the manufacturer regarding device functionality post-op.It was reported that the surgeon suspected that patient death was caused by leaflet blockage.

• 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 13040 ; IT 13040
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 16946724
• MDR Text Key: 315389384
• Report Number: 3005687633-2023-00113
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012906
• UDI-Public: (01)08022057012906(240)S5-021(17)270419
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• 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
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2022
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 74 KG