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

Model Number	CNA19
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Death (1802); No Information (3190)
Date of Event	04/13/2020
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2019, crown/prt (cna19, sn# (b)(4)) was indwelled through a midline incision, at the same time, coronally artery bypass graft surgery was performed.The patient had a small annulus and had an aortic regurgitation.At the time of implanting surgery, the surgeon intended to implant edwards' magna 21 mm, but the sizer didn't easily pass the annulus.Therefore crown 19 mm was selected.No abnormalities were observed at the time of implantation.After discharge from the hospital, the patient's condition did not improve so much, and an abnormality was confirmed by echo.Crown was removed on (b)(6) 2020, and part of the stent was deformed into an elliptical shape.Edwards insprirs was implanted after the crown was removed, and the patient subsequently died.
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 quality engineering at livanova canada corp.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.The device was returned to the manufacturer for analysis.A gross and visual inspection was performed.The returned valve prosthesis was received in a plastic jar without storage liquid.Despite the storage dry conditions, the prosthesis was still wet.The valve appeared dark and with the sewing cuff almost completely removed.The returned prosthesis was inspected and a deformation was noted consistent with the description on in the case history: and part of the stent was deformed into an elliptical shape.The pericardium appeared normal and without pre-existing defects.A dark area in a portion of the pericardium of post#1 was detected.The sewing cuff was almost completely removed from the valve.An x-ray analysis confirmed no traces of calcification on the leaflets.An inspection of the stent geometry was performed.The inspection of the stent revealed a deformed structure.In addition, large damaged areas were detected and reasonably identified as contact points with cautery on the basis of the evidence found: traces of burning/plastic re-fused areas between acetylic (stent) and dacron polyester material.Based on the performed analysis, it is not possible to provide a final judgment on the device and the stent shape / geometry.It is not possible to verify if the deformation reported in the complaint is consistent with the large deformation observed in analysis.The deformation of the leaflets suggests a pre-existing deformation of the valve body (stent), however the removal / explant procedure cannot be ruled out as a contributory cause.Considering the alteration on the stent due to the explanting manipulation (contact with cautery), it is not possible to provide a judgement about the entity of the deformation before the explant.In addition, it is not possible to exclude that the deformation is associated with a mishandling during the implanting phase.At this time the root cause can ultimately not be established.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 10064009
• Report Number: 1718850-2020-01081
• Device Sequence Number: 3514810
• Product Code: LWR
• UDI-Device Identifier: 00896208000504
• UDI-Public: (01)00896208000504(240)CNA19(17)210531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020
• Report Date (Section F): 04/16/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: CNA19
• Device Catalogue Number: CNA19
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/16/2020
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 05/16/2020
• Supplement Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 74 YR