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

Model Number	PVS21
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was notified of an intra-operative explant of a perceval s sutureless aortic valve pvs21 / size s that occurred on (b)(6) 2023 during an isolated avr procedure performed through mini sternotomy.Reportedly, one of the leaflets was appearing more tensioned than the others, resulting in insufficient coaptation.The prosthesis was thus replaced with another perceval valve of the same size with a good outcome, as confirmed by the intraoperative tee check.Approximately 30 minutes of clamping time and 45 minutes of perfusion time were added to the procedure without adverse consequences to the patient, who remained stable throughout the delay in surgery.As per additional information received, patient's native valve was functional bicuspid and there were no abnormal geometries in the patinet's annulus, as confirmed by the pre-operative assessment performed through ct and ultrasound.Pre-operative assessment also confirmed an stj-annulus ratio < 1.3, which is in accordance to the patient anatomical characteristics inidcated in perceval valve ifus.It was confirmed that the sizing procedure was performed according to protocol and a complete decalcification of the annulus was performed prior to implanting the perceval valve involved in the event.
Additional Manufacturer Narrative
The manufacturer is following up on the return of the device, as the prosthesis involved has not yet been received, and will submit a follow-up report upon receipt of the device or further information.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval heart valve, model #icv1208, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a (model #icv1208) perceval heart valve at the time of manufacture and release.The involved perceval s prosthesis was returned to the manufacturer for analysis and was received in general 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 hydrodynamic test was then conducted applying experimental conditions in accordance with the en iso 5840:2021.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean backpressure of 100 mmhg was 2.20 cm2, above the iso 5840 minimum requirement of 1.05 cm2.For a cardiac output of 5.0 l/min and mean aortic pressure of about 100 mmhg, the regurgitant fraction was 3.3 % which is in compliance with the requirement of iso 5840 (rf% < 10%) for a prosthesis of equivalent size.Regarding the full coaptation of the leaflets, no anomalies were observed during the open/close cycle in normotensive conditions; in hypotensive conditions, which, although not representative of normal functioning, were tested to evaluate the possible valve behaviour during the weaning phase of the surgery, a slight central leakage was detected.As for the reported appearance of one of the leaflets, which seemed to be more tense and was evaluated as providing insufficient coaptation, the manufacturer noted that, actually, one of the leaflets appears slightly tensioned when observing the valve on the bench, in non-working conditions; this appearence is also barely noticeable in the images taken during the hydrodynamic test in normotensive conditions with the prosthesis in open configuration.It should be noted though that it was not detectable on the pictures documenting the steady flow test performed at the time of manufacture and release and in those documenting the valve behaviour in closed configuration during the hydrodynamic test in normotensive conditions, however, as documented by the results of the hydrodynamic test, the above mentioned appearance does not compromise the correct and complete coaptation of the prosthesis in any way.In conclusion, based on the performed analysis, the claimed issue (insufficient coaptation) was not confirmed by the investigation carried out (i.E.Hydrodynamic test) whose results were in compliance with the standard of en iso 5840:2021.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• 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: 18279748
• Report Number: 3004478276-2023-00210
• Device Sequence Number: 12328286
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)260908
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P150011
• 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,Followup
• Report Date (Section B): 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2026
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 12/12/2023; 12/20/2023
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 01/10/2024; 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• 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
• Patient Age: 71 YR
• Patient Sex: Female