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

Model Number	CPHV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	04/18/2023
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005687633-2023-00113
• Device Sequence Number: 14016188
• Product Code: LWQ
• UDI-Device Identifier: 08022057012906
• UDI-Public: (01)08022057012906(240)S5-021(17)270419
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2023

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2022
• 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: Death
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 74 KG