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

Model Number	CNA21
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, a patient with aortic stenosis was intended to receive a crown cna21.It was reported that post-pump, the transesophageal echo was performed, finding dysfunction of the newly implanted prosthesis due to moderate central insufficiency, no leakage.It was decided to change the newly implanted prosthesis, concluding structural and functional damage; a porcine pericardium is placed (valve porcino hankco ii).The explanted valve is reviewed and structural damage is observed in one of its leaflets, which does not allow adequate coaptation.As a result of the event, the surgical times were prolonged (prolongation of the pump time and prolongation of the aortic clamp time).However, it was reported that the patient progressed well.The patient had a satisfactory recovery.
Event or Problem Description
On (b)(6) 2021, a patient with aortic stenosis was intended to receive a crown cna21.It was reported that post-pump, the transesophageal echo was performed, finding dysfunction of the newly implanted prosthesis due to moderate central insufficiency, no leakage.It was decided to change the newly implanted prosthesis, concluding structural and functional damage; a porcine pericardium is placed (hancock ii porcine valve, number 21).The explanted valve is reviewed and structural damage is observed in one of its leaflets, which does not allow adequate coaptation.As a result of the event, the surgical times were prolonged (prolongation of the pump time and prolongation of the aortic clamp time).However, it was reported that the patient progressed well.The patient had a satisfactory recovery.Per additional information received, the surgeon claims to have made the correct measurement and valve placement, no suspected root causes were identified.The pre-operative conditions of the patient showed severe calcific aortic stenosis with a mean gradient of 100 mmhg, with an ejection fraction of 50%, valve area 0.4 cm2; normal coronaries.At intraoperative evaluation with transesophageal echo, moderate-severe eccentric valve insufficiency was documented, involving more than 50% of the lv outflow tract, with limitation of the opening of the anterior mitral valve.Faced with this finding, the extracorporeal circulation was restarted, passage of new cardioplegia, the valve was explanted with subsequent implantation of the hancock ii no.21 biological valve; the patient was weaned from the cardiopulmonary bypass without problems, the control with transesophageal echo documented a normal implanted valve, without paravalvular leaks, without insufficiency.Postoperative progress was without complications, amd the patient was discharged on the 7th day postsurgical.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
After decontamination with formalin treatment, the valve was visually inspected identifying the presence of: about a dozen suture stitches in about half of the development of the sewing cuff of the prosthesis.Some damage compatible with the handling resulting from the explant including some minor cuts or abrasions on the leaflets.The leaflets are able to coapt despite the pericardium appearing slightly rigid probably due to the storage conditions.The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna21, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by 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, including a review of the function test which confirmed synchronous opening and closing with smooth, continuous motion and no leaflet fluttering.Based on the investigations performed, the reported event of central leak cannot be explained by any factors intrinsic to the returned device.No elements of non-conformity, specifically no coaptation issues or no structural damages to the leaflets, were identified on the returned device during the analysis conducted.Based on the manufacturer¿s clinical experience, where the investigation did not reproduce any device malfunction, the possible root causes related to events of intra-operative central leak could be related to device misizing or device mispositioning.Although the information received identified no concerns on the sizing nor on the positioning, considering the orifice/inner diameter comparison between the crown cna21 (17.3mm) versus the hancock ii no.21 (18.5mm), a possible root cause for the reported event could be identified in a device mis-sizing.Since however the patient¿s annulus dimensions were not provided, this cannot be ultimately confirmed.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby V5J 5 M1; CA V5J 5M1
• MDR Report Key: 11639006
• Report Number: 1718850-2021-01048
• Device Sequence Number: 3160032
• Product Code: LWR
• UDI-Device Identifier: 00896208000511
• UDI-Public: (01)00896208000511(240)CNA21(17)240930
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2021
• Report Date (Section F): 07/31/2021

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: 09/30/2024
• Device Model Number: CNA21
• Device Catalogue Number: CNA21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/31/2021
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/10/2021; 08/27/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/13/2021; 08/27/2021
• 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: Required Intervention
• Patient Age: 62 YR