MAUDE Adverse Event Report: CORCYM S.R.L. PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number	PVF-L
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Aortic dissection (4870)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A perceval plus size l valve was attempted to be implanted on (b)(6) 2025 through mini-sternotomy.The patient presented with aortic valve insufficiency.Pre-operative assessment was conducted through ct and the patient was initially indicated for aortic repair.However, after opening the aorta, it was assessed that the leaflets were too heavily calcified, therefore it was decided to proceed with leaflet resection and perceval valve implantation.The evaluation of pre-operative ct scans was suggestive of a size l and confirmed that stj/annulus ratio was adequate for perceval valve implant.The patient¿s native valve was tricuspid.Sizing was performed intra-operatively and size l was confirmed to be adequate.No issues were reported during valve preparation or positioning.The valve position was checked, and the valve appeared well seated according to the surgeon¿s assessment (no anulus visible, no coronary ostia obstruction, good valve appearance in situ).After aortotomy closure, tee revealed abnormal prosthetic movement, with the valve fluctuating in the lcc area above the left coronary commissure.The patient was put back on-pump.Reopening of the aorta showed partial valve migration.An incision was identified in the ascending aorta at the site corresponding to the prosthesis movement seen on tee.The procedure was converted to a full sternotomy, and the valve was explanted.The torn section of the aorta was resected, and an edwards intuity size 23 valve along with a straight dacron graft size 28 were implanted.Subsequent bleeding from the aortic cannulation site was noted and corrected.No concomitant procedures were performed.The patient was extubated the following day, transferred out of the icu the day after, and is reportedly doing well.
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.The manufacturer has received the device involved, a follow-up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
Updated sections: b4, g3, g6, h2, h3, h6, h11.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.Both the relyon pak l accessory kit used and the involved valve, in its original jar filled with an unknown liquid, were returned to the manufacturer.The returned prosthesis appeared to be in generally good storage conditions.After decontamination, the valve was visually inspected without highlighting elements of non-conformity according to the specifications.The height of each leaflet was verified by means of the specific tool resulting in conformity.A dimensional analysis was performed, which confirmed the compliance of the returned device with the specifications.In order to verify the correct sealing of the prosthesis, a replication the deployment phase was performed using the returned valve and the returned accessory kit.During the simulated deployment within a silicone aortic root model (#25), no issues were observed during either the release or balloon inflation phases.Adequate sealing at the annulus level was achieved, and the valve remained securely positioned within the annulus.Subsequently, water was introduced into the aortic root from the outflow side.No paravalvular leakage was observed during the simulation.Under the static conditions of the test, the water level remained stable below the free edge of the leaflets.In conclusion, based on the analysis performed, a device-related issue can be ruled out, as the reported event could not be reproduced: no paravalvular leaks were observed during the static leak test, and the valve¿s positioning, stability and sealing performance were confirmed.Additionally, the document review did not reveal any manufacturing deficiencies.According to the medical judgment provided, an unintended mispositioning of the perceval valve (slightly tilted relative to the aortic axis) cannot be excluded as the root cause of the abnormal valve movement and the subsequent aortic tear.Moreover, given how easily the patient¿s aorta ruptured, along with the bleeding from the aortic cannulation site, underlying tissue fragility in the patient is suspected.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; via per crescentino sn; saluggia, vc 13040 ; IT 13040
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 24321711
• Report Number: 3004478276-2026-00117
• Device Sequence Number: 18497676
• Product Code: LWR
• UDI-Device Identifier: 08022057015389
• UDI-Public: (01)08022057015389(240)PVF-L(17)290510
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• 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,Followup
• Report Date (Section B): 03/23/2026

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-L
• Device Catalogue Number: PVF-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2026
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2025
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 68 KG