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

Model Number PVF-S

Device Problem Incomplete Coaptation (2507)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/30/2024

Event Type  Injury  

Event Description

The manufacturer was informed of an intra-operative explant of a perceval plus sutureless aortic bioprosthesis size s that occurred on (b)(6) 2024.Reportedly, at the transesophageal echo check performed intra-operatively, a coaptation issue was detected which resulted in massive central leak.There were no signs of perivalvular leak.As reported, the perceval valve was replaced with a new one of the same size.This required to stop the heart again, restart bypass with clamping and reopening of the aorta and resulted in a lengthening of surgical time of approximately 1hr and 30 min.

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 pvf-s prosthesis involved in the event was returned to the manufacturer for analysis.The device was received in general good storage conditions.After decontamination, the valve was visually inspected without detecting macroscopic anomalies and/or pre-existing defects according to specifications.The dimensional analysis performed confirmed the correct dimensions of the returned device, including the height of each leaflet which was found to be compliant.At the hydrodynamic testing, no anomalies were observed during valve opening and closing phase under normotensive and hypotensive conditions.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean backpressure of 100 mmhg was 2.65 cm2, above the iso 5840:2021 minimum requirement 1.05 cm2.For a cardiac output of 5.0 l/min and mean aortic pressure of about 100 mmhg, the regurgitant fraction was 4.4 % , which is below the requirement of iso 5840:2021 (rf% < 10%) for a prosthesis of equivalent tad.Based on the performed analyses, it is possible to exclude the relationship between the reported issue and the returned device quality.The review of the data filed in the device history record of the returned perceval plus heart valve sn (b)(6), confirmed that the prosthesis satisfied all material, dimensional, and performance standards required for a perceval valve pvf-s at the time of manufacture and release, including an open-close test.The visual inspection performed on the returned device did not highlight pre-existing defects and the dimensional analysis confirmed the absence of dimensional irregularity, confirming that the returned pvf-s valve meets the specifications.At the hydrodynamic testing, no anomalies were observed during the open/close cycle under normotensive and hypotensive conditions and the returned pvf-s was found to meet the en iso 5840:2021 minimum requirements.As per medical judgement received, the patient's annulus was very smalla and it is possible that the valve was constrained thus causing the observed coaptation issue.Since a perceval valve of the same model and size was ultimately implanted, it is more likely though that the event was caused by a sub-optimal positioning of the prosthesis rather than to the specific patient's anatomy.It is also possible that the reported coaptation issue have been observed due to the fact that the tee was acquired at a very early stage of the weaning phase, when the valve was not under adequate pressure conditions, although, based on the available information, this cannot ultimately be confirmed.

Event Description

The manufacturer was informed of an intra-operative explant of a perceval plus sutureless aortic bioprosthesis size s that occurred on (b)(6) 2024 during an isolated avr performed through mini thoracotomy.Reportedly, at the transesophageal echo check performed intra-operatively, a coaptation issue was detected which resulted in massive central leak.There were no signs of perivalvular leak.As reported, the perceval valve was replaced with a new one of the same size.This required to stop the heart again, restart bypass with clamping and reopening of the aorta and resulted in a lengthening of surgical time of approximately 1hr and 30 min.Based on further details received from the implanting site, the patient anatomy was characterized by a tricuspid aortic native valve with a very small annulus and a septal bulge.According to the medical judgement received, it was assessed that the valve was constrained and this could have led to the observed coaptation issue.At first instance, a leaflet malfunction was suspected, but no anomalies were noted on the valve at the visual inspection.As reported, no collapsing difficulties were experienced.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Type of Device: 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: 18980913
• MDR Text Key: 338659474
• Report Number: 3005687633-2024-00103
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 08022057015365
• UDI-Public: (01)08022057015365(240)PVF-S(17)270907
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P150011/S013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVF-S
• Device Catalogue Number: PVF-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention