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

Model Number PVS23

Device Problem Leak/Splash (1354)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209 , s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by the manufacturer's quality engineering, including a review of the steady flow test.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1209) perceval heart valve at the time of manufacture and release.The review of the steady flow test confirmed that no anomalies were observed in the valve during the open/close cycle.Copies of the echocardiography performed were received and reviewed by an external consultant.The tte dated (b)(6) 2021 is of poor quality and has low image count.It shows normal lv function (ef 55-60%) and normal rv function.Valvular evaluation shows trivial ar and trivial mr.No pericardial effusion is seen.The tee dated (b)(6) 2021 shows that the anterior aortic prosthetic leaflet is thickened and with reduced mobility, suggesting leaflet thrombosis.There is mild central ar and the prosthetic valve seems to be in good position.The manufacturer has requested additional information on this event, but none has been provided to date.Since the device remains implanted, no further investigation is possible at this time.Based on the investigation performed and information available, it is not possible to provide a final judgment on the event and the device.However, from the document review performed, no manufacturing deficiencies were identified.Considering that a moderate central leak was present since the time of implant, the postoperative finding of central aortic insufficiency can be considered as a stable condition present since the time of implant, rather than to a late inception of a dysfunction of the device.Based on the manufacturer¿s clinical experience, possible root causes for events of intra-operative central leak could be related to procedural factors like device missing or device mispositioning.However, this can not be ultimately confirmed based on the available information and given that no inspection on the device was possible.Furthermore, although the echo imaging review suggests a possible thrombosis, this information was not received from the site.Ultimately, since the patient's conditions were stable and no device-reintervention occurred, there is no evidence to suspect a serious injury for the patient as a result of the reported event.Should any further information be received, a follow-up report will be provided.Device remains implanted.

Event Description

On (b)(6) 2021, a perceval size m was implanted as part of an aortic valve replacement procedure.A concomitant cabg (lita-lad svg-4pd) was performed.The cross-clamp duration was 208 min.Transesophageal echocardiography after declamping showed a mild-level central leak.On (b)(6) 2021, the transesophageal echocardiography was performed again, and it was confirmed that central leak of mild-trace remained.The patient's condition was stable and the patient's discharge was planned after rehabilitation.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: 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: francesca crovato ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 14690936
• MDR Text Key: 301365383
• Report Number: 3004478276-2022-00156
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)230709
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2023
• Device Model Number: PVS23
• Device Catalogue Number: CV1209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2020
• 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): Other
• Patient Age: 77 YR
• Patient Sex: Male