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

Model Number	PVF-S
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Transvalvular Pressure Gradient Increased (4854)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is currently following up with the involved healthcare facility and performing the review of the production records.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The manufacturer was informed of an event involving a perceval plus valve, size s (pvf-s), reportedly implanted on (b)(6) 2025.Concomitant procedures included mitral valve replacement and tricuspid valve repair, with a medtronic mosaic prosthesis placed in the mitral position.During the operation, the aorta was opened and evaluated.Calcifications were removed, and the annulus was sized for the perceval valve.The surgical team then proceeded with the mitral valve procedure before returning to the aorta, resizing it, and ultimately implanting a size small perceval plus.Ballooning was performed in accordance with the ifu.Tricuspid valve repair was completed following the implantation of the pvf-s valve.Postoperative tee revealed no abnormalities.However, a subsequent echo evaluation by a cardiologist indicated a significantly elevated gradient one week after surgery.The mean gradient was reportedly 12 mmhg immediately postoperatively in the operating room, rising to approximately 23 mmhg four to five days later.Additionally, a leak was detected, though its origin, central or paravalvular, could not be confirmed.A ct angiography revealed infolding on one side of the inflow portion of the perceval valve.The patient subsequently underwent balloon valvuloplasty using a nucleus size 22 balloon to expand the prosthesis.During the reintervention, the infolding appeared less pronounced than initially observed.The procedure was successful, with no further evidence of stent folding, and the patient is reportedly doing well.Based on the information received, no malpositioning or sizing errors were identified, and no cardiac manipulation, such as cpr, was performed following the implantation of the perceval valve.
Additional Manufacturer Narrative
Updated sections b4, g3, g6, h2, 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.The device remains implanted and therefore is not accessible for testing.As such, further investigation cannot be performed.Post-operative perceval stent folding is an extremely rare condition which impairs proper valve function.Potential contributing factors include inadvertent oversizing, variations in aortic root anatomy that deviate from the normal tri-symmetrical geometry (such as a bicuspid valve or absence of one valsalva sinus), interaction with heavily calcified segments of the annulus, or uneven decalcification resulting in bulky calcium protrusions.Based on the manufacturer¿s experience and the analysis of the available data, a definitive root cause for the reported event cannot be established.Furthermore, the document review revealed no evidence of manufacturing deficiencies.

• 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 S.R.L.; via per crescentino sn; saluggia, vc 13040 ; IT 13040
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 23533567
• Report Number: 3005687633-2025-00133
• Device Sequence Number: 9021432
• Product Code: LWR
• UDI-Device Identifier: 08022057015365
• UDI-Public: (01)08022057015365(240)PVF-S(17)290213
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 10/14/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2025
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 70 KG