MAUDE Adverse Event Report: CORCYM S.R.L. CARBOMEDICS STANDARD AORTIC PROSTHETIC HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	CPHV
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complete manufacturing and material records review for the cphv valve a5-021 has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.The manufacturer is following up to retrieve further information regarding this event and the device involved.A follow up report will be provided upon receipt of any additional information or/and the actual device.
Event or Problem Description
The manufacturer was informed of an intra-operative explant of a carbomedics standard prosthetic aortic heart valve size 21.Reportedly, the valve was fractured during the implant phase of the surgery.Another aortic valve of the same brand but smaller size (a5-019) was implanted instead, and the operation was completed.No further information is available at this time.
Additional Manufacturer Narrative
Corrected fields: d9, h1 h3 other text : device evaluation is ongoing.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the cphv valve a5-021 sn (b)(6) involved in the reported event has been performed, including: an additional verification carried out on the x-ray of the pyrolite carbon coated leaflets to exclude voids, flaws, and irregularities in the internal structure of the leaflet; proof function tests performed on the separate leaflets and on the assembly.These tests are followed by dye liquid penetrant inspection with the aim to determine component failures.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the examination of the returned carbomedics valve, the root cause of the reported event can be thus traced to inadvertent mishandling of the device during implant, which caused a load, exceeding the ultimate strength of the pyrolytic carbon, to be applied to the leaflet, causing local over-loading of the component and finally resulting in the leaflet breakage and escaping.It should also be noted that, ultimately, a mechanical valve of the same model but smaller size was implanted.An initial mis-sizing could have led to difficulties in implanting the prosthesis leading to inadvertent mishandling, even though this cannot be ultimately confirmed since further decalcification of the patient annulus could have been performed prior to implanting the definite device.

• Brand Name: CARBOMEDICS STANDARD AORTIC PROSTHETIC HEART VALVE
• Common Device Name: 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: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 18422240
• Report Number: 3005687633-2023-00133
• Device Sequence Number: 18186135
• Product Code: LWQ
• UDI-Device Identifier: 08022057012616
• UDI-Public: (01)08022057012616(240)A5-021(17)280611
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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,Followup,Followup
• Report Date (Section B): 03/01/2024

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: A5-021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/06/2023
• Supplement Date Received by Manufacturer: 12/27/2023; 02/02/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 01/26/2024; 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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: Required Intervention
• Patient Sex: Female