MAUDE Adverse Event Report: CORCYM CANADA CORP. CROWN PRT PERICARDIAL HEART VALVE; TISSUE HEART VALVE

Model Number CNA21

Device Problem Leak/Splash (1354)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 06/14/2022

Event Type  Injury  

Manufacturer Narrative

Not returned from site.

Event Description

On (b)(6) 2022, inspiris valve was attempted to be implanted.However, the device crown prt pericardial heart valve cna19 was selected and implanted because the inspiris sizer 19mm was tight.After de-clamp, echo showed regurgitation.Echo could not determine whether it was paravalvular leakage or transvalvular leakage.It seemed to be pvl or tvl closer to the stent post.Since the leakage was mild, the device was explanted and the inspiris 19mm was implanted instead finally.After de-clamp, echo showed no leakage and the operation was completed without any problem.The concomitant procedure was an ascending aorta replacement.Operation time was added 60 minutes because of this event.The patient remained stable throughout delay in procedure.The patient outcome is no problem, the patient weaned uneventfully and there was no patient impact.As reported, the patient¿s annulus dimensions measured pre-operatively was approximately 19mm.The crown 19 was implanted supra annularly.No decalcification was performed after the crown valve explant and the inspiris valve implant.

Manufacturer Narrative

The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna19, 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 crown prt aortic pericardial heart valve at the time of manufacture and release.Based on the information available, the diameter of the annulus was 19mm and the crown valve size 19 was implanted supraannularly.As such, comparing the internal diameter of the cna19 (15.4 mm as indicated in the information table for the device) and the annulus diameter of the patient (19 mm as reported), the root cause of the reported event can be attributed to the mis-sizing (use-error).

• Brand Name: CROWN PRT PERICARDIAL 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: 14981328
• MDR Text Key: 295679525
• Report Number: 3004478276-2022-00166
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000504
• UDI-Public: (01)00896208000504(240)CNA19(17)231130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060038
• 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: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 11/30/2023
• Device Model Number: CNA21
• Device Catalogue Number: CNA21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• 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: 80 YR
• Patient Sex: Female