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	Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	12/26/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The manufacturer is following up with the site to retrieve additional information on the event and the device involved.A follow up report will be submitted upon receival of new information or completion of the investigation.
Event or Problem Description
The manufacturer was informed of an intra-operative explant of a perceval plus pvf-l prosthesis occurred on (b)(6) 2023 during an isolated aortic valve replacement surgery performed through full sternotomy.As reported, the patient's native valve was tricuspid, stenotic and heavily calcified.At the pre-operative ct scan, the annulus size was measured to be 23.5 mm.Reportedly, no difficulties were encountered in the collapsing and positioning of the perceval prosthesis and no malpositioning or mis-sizing were noted.Post implantation, perivalvular leak was observed around the valve, therefore the prosthesis was explanted and re-implanted but the same issue was occurring.So, it was decided to implant a stented valve from a different manufacturer (medtronic avalus 25mm) instead.Reportedly, the patient was frail and, despite being stable during the re-exploration, did not survive due the prolonged cpb time (over 3 hours) and multiple exposures.
Additional Manufacturer Narrative
Updated fields: 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 the material, visual, and performance standards relevant to the reported event at the time of manufacture and release.The perceval prosthesis involved in the reported event was returned to the manufacturer for analysis and appeared in general good storage conditions.After decontamination, the valve was visually inspected without observing any macroscopic anomalies and/or pre-existing defects according to the specifications.A dimensional analysis was performed which confirmed the correct dimensions of the returned device.In order to attempt to reproduce the reported event, a replication of the collapsing phase was performed using the returned valve pvf-l and a demo accessory kit.No problems were encountered in the collapsing phase, and the replication was completed with a good result.Valve deployment was simulated in silicon aortic roots #23 and #25 and no problems were encountered during the ballooning phase; the sealing at the annulus level was guaranteed and the valve remained fixed within the annulus.Then, inserting some water in the aortic root from the outflow side, no paravalvular leaks were observed during both the simulations.Considering the static conditions of the test, the water level remained stable under the leaflets free edge.Based on the performed analyses, it is possible to exclude the relationship between the reported issue and the returned device quality.On the other hand, according to the manufacturer¿s experience, it cannot be ruled out that the observed pvl was due to a deformation of the stent at the level of the sealing collar potentially induced by protruding intra-luminal calcifications.As reported in perceval plus ifu, even if complete intra-annular decalcification of the annulus is not necessary, eccentric/bulky protruding intra-luminal calcifications could impair strut expansion.In the present case, it was reported that the patient¿s native valve was heavily calcified; as such an uneven distribution of calcium residuals could have impaired a correct valve expansion thus leading or contributing to the observed pvl.It should also be noted that, as per perceval plus ifus, a removed perceval plus prosthesis must not be re-implanted, because its integrity is no longer ensured.As such, the decision to re-implant the perceval prosthesis was made off-label.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 19326405
• Report Number: 3005687633-2024-00107
• Device Sequence Number: 15204694
• Product Code: LWR
• UDI-Device Identifier: 08022057015389
• UDI-Public: (01)08022057015389(240)PVF-L(17)260516
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P150011S013
• 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
• Report Date (Section B): 06/14/2024

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 Expiration Date: 05/16/2026
• Device Model Number: PVF-L
• Device Catalogue Number: PVF-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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; Death
• Patient Age: 77 YR
• Patient Sex: Male