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

Model Number PVS21

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 04/08/2022

Event Type  Injury  

Event Description

The procedure was scheduled as a mini avr plus root enlargement.On (b)(6) 2022, the perceval valve size 21 was implanted.While checking the valve, it was noticed that the valve was seated too high in the aorta.It was decided to explant the valve, re-collapse, and re-implant the prosthesis.On the second attempt of implant, the valve was seated appropriately.Then, the valve was ballooned with a warm saline bath for 30 seconds, and aorta was closed.During the echo it was noticed that the valve had seated too high and was at the coronary level.At this point, the operation was converted to full sternotomy and an edwards magna ease size 19 valve was implanted.After the implantation of the magna ease the patient experienced complications not related to perceval valve.(the reported complications after the implant of magna ease are as follows: right side of the heart was not working, it was difficult to come off bypass, the patient was put on ecmo, and tearing in the aorta was occurred).

Manufacturer Narrative

Retained by site.

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 satisfied all material, visual, and performance standards required for a (model #icv1208) perceval heart valve at the time of manufacture and release.Since the device was not returned to the manufacturer, further investigation cannot be performed.Based on the information available, there is no evidence suggesting the relationship between the reported event and the corcym's device.Furthermore, as reported, the valve was explanted, re-collapsed, and attempted to be re-implanted.In this regards, as explained in the perceval valve instructions for use, ''a removed perceval prosthesis must not be re-implanted, because its integrity is no longer ensured.'' as such, the decision to re-collapse the valve was made off-label.Should further information be received in the future, a follow up report will be provided.

• 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: 14294327
• MDR Text Key: 290929445
• Report Number: 3004478276-2022-00144
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)230116
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2023
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• 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
• Patient Age: 81 YR
• Patient Sex: Female