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

Model Number PVS23

Device Problem Difficult to Open or Close (2921)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 09/08/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a perceval valve pvs23 implant attempt occurred.After the implant the leaflets appeared stiff.The valve was explanted and replaced with a perimount valve size 21.Based on additional information provided, the valve collapsing and preparation was performed as usual, no anomalies were detected.The valve positioning in the dual collapser occurred with no problem and the valve was collapsed normally.The valve was stored in saline solution prior to the implant.After the valve implant and declamp, the echo showed that the valve leaflets were "frozen" (i.E.Blocked in the open position).The valve was not closing and the echo findings showed a massive aortic insufficiency.The valve appeared well positioned.The bypass was restarted and the valve inspected.The leaflets appeared not to close properly and were immobile.No cusp tears were identified, but the leaflets appeared thickened.There was no adverse event for the patient who was already discharged after finally implanting perimount valve 21 instead.

Manufacturer Narrative

The device returned to the manufacturer for investigation.The returned prosthesis was received in a bad state of conservation.On the 1st and 3rd leaflets there are 2 spots (they look like mold).The height of each package leaflet was checked using the specific tool and it resulted in compliance.The dimensional check carried out did not reveal any anomalies.The visual inspection did not highlight any pre-existing defects.The valve in question therefore complies with the required specifications.Considering the bad state of conservation of the returned prosthesis, it was not possible to perform any further analysis on the returned prosthesis.The manufacturing and material records for the perceval heart valve, model #icv1209, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.This review included the steady flow test inspection performed at the time of manufacture and release of the prosthesis in question.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 steady flow test review demonstrate the acceptable opened and closed leaflet performance of the perceval pvs23 sn# (b)(6).No anomalies are observed during the open/close cycle.The valve therefore meets the acceptance criteria of the steady flow test inspection as defined in the principal device function test at the time of release.Based on the investigations performed, no product malfunction was identified in the returned prosthesis.Although the prosthesis was received in a bad conservation state, no elements of non conformities were identified in the prosthesis, which resulted in compliance with the manufacturer's specifications for a model icv1209/pvs23.Furthermore, the review of the steady flow test performed at the time of manufacture and release of the valve confirmed a good leaflets functionality.Ultimately, considering the results of the investigation and the available information, a definitive root cause for the reported event cannot be established at this time.

• 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
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 12595485
• MDR Text Key: 278761678
• Report Number: 3004478276-2021-00265
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)240403
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2024
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2020
• 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): Required Intervention