MAUDE Adverse Event Report: CORCYM S.R.L. CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP); HEART VALVE, MECHANICAL

Model Number	AP-027
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the device involved in this event, as they pertain to the reported issue, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this prosthesis satisfied all required material, visual, and performance standards at the time of manufacture and release.From the document review performed, no manufacturing deficiencies were noted.Based on the medical judgement received, the patient had very poor-quality tissues which were related to the tear.As such, the cause of the event can be traced to patient condition.
Event or Problem Description
The manufacturer was notified of an intraoperative explant involving carboseal ascending aortic prosthesis through device tracking.Based on the information available, a carboseal ascending aortic prosthesis ap-027 was attempted to be implanted as follows: the surgeon was doing a bentall procedure (valve/aortic root replacement).Sized for a carboseal 27 (ap-027).Put the sutures in the annulus in the normal fashion, followed by putting them through the sewing cuff of the valve.Lowered it down into place and started tying it in on one side.When the surgeon began tying the valve in on the opposite side, a pop was felt.Through inspection, it was noticed that the lvot on the left size had been torn and there was then a hole.As such, they had to remove the carboseal, repair the tissue and at that time decided to implant a graft (terumo gelweave), followed by a top hat aortic valve s5-025 inside the graft to keep it supra-annular and away from the repair on the heart as well as the graft anastomosis.The patient recovered fine and has since been discharged home.Based on the medical judgment received, the patient had very poor-quality tissues which were related to the tear.

• Brand Name: CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP)
• Common Device Name: HEART VALVE, MECHANICAL
• Manufacturer (Section D): CORCYM S.R.L.; via per crescentino sn; saluggia, vc 13040 ; IT 13040
• Manufacturer (Section G): CORCYM S.R.L.; via per crescentino sn; saluggia, vc 13040 ; IT 13040
• Manufacturer Contact: laura mannino ; via per crescentino sn; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 25647273
• Report Number: 3005687633-2026-00110
• Device Sequence Number: 20299688
• Product Code: LWQ
• UDI-Device Identifier: 08022057013491
• UDI-Public: (01)08022057013491(240)AP-027(17)270301
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 06/27/2026

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: AP-027
• Device Catalogue Number: AP-027
• 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: 05/29/2026
• Initial Report FDA Received Date: 06/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2024
• 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 Age: 34 YR
• Patient Sex: Unknown