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

Model Number	CNA21
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not returned from site.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3004478276-2022-00166
• Device Sequence Number: 20241754
• Product Code: LWR
• UDI-Device Identifier: 00896208000504
• UDI-Public: (01)00896208000504(240)CNA19(17)231130
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• 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: 80 YR
• Patient Sex: Female