MAUDE Adverse Event Report: CORCYM CANADA CORP. PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number	PVF-S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Rupture (2208)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer is retrieving further information including the confirmation of the device serial#; and will submit follow-up report upon availability of new, relevant details.
Event or Problem Description
On (b)(6) 2025, a perceval plus valve pvf-s was implanted with mics avr.After confirming no pvl by (b)(6), bleeding was noted in unknown place.A median incision was made to find the bleeding point, and the left atrial area was suspected.Reportedly, the white sizer was not inserted, but it was decided to implant a s size sizer, which was dilated 4atm 60 seconds later.The following were suggested: (1) rupture of the arterial valve ring due to perceval placement; (2) rupture by the duct catheter in the left atrium; and (3) rupture of pa.Thereafter, clamping and de-clamping was repeated to stop bleeding, but hemostasis was not completed.Hemostasis with gauze packing was performed as best as possible, and the patient left the room after it was confirmed that the chest can be closed under ecmo.Subsequent status could not be confirmed.The surgery time was extended 5 hours due to this incident.
Additional Manufacturer Narrative
Updated fields: b4, d4, g3, g6, h2, h6.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.Manufacturer is following up to retrieve further information regarding the event and the device involved.A follow up report will be provided upon receipt of any further information as applicable.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6.Manufacturer attempted to follow up with the site, but no further information has yet been received.Since limited information is available and the device was not returned to the manufacturer for further investigation, the definitive root cause of the reported event cannot be established.However, from the document review, no manufacturing deficiencies were noted.Medical judgment provided, suggested some possible root cause for the reported event but since limited information is available, they cannot ultimately be confirmed.Should further information be available in the future, a follow up report will be provided.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 22741777
• Report Number: 3004478276-2025-00164
• Device Sequence Number: 14806041
• Product Code: LWR
• UDI-Device Identifier: 00896208000795
• UDI-Public: (01)00896208000795(240)PVF-S(17)281220
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 01/14/2026

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: PVF-S
• Device Catalogue Number: PVF-S
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 08/20/2025; 01/14/2026
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/18/2025; 01/14/2026
• 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: Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 54 KG