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

Model Number PVS21

Device Problems Perivalvular Leak (1457); Malposition of Device (2616); Patient-Device Incompatibility (2682)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 12/09/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a perceval valve pvs21 was implanted and explanted on the same day.The patient had a type 1 bicuspid valve.Valsalva sinus had a normal shape.After the aortic incision, the shape was such that there was no boundary between the noncoronary cusp and the right coronary cusp.Also, nadir was not seemed uniform in height.After the s size perceval was placed, it was visually confirmed that the valve was slightly tilted.After de-clamping, perivalvular leakage (trace to mild) occurred.Also, the right coronary cusp did not open or close at all.The device was removed.Since the patient had a bicuspid valve, it was judged that the same event would occur even if the sutureless valve was implanted again.Thus, a conventional valve (unknown details) was implanted.

Manufacturer Narrative

The device involved in the reported event was returned to the manufacturer for investigation.The valve received has no pre-existing defects.In general, it is still in good condition.The height of each leaflet has been verified by means the specific tool, and it resulted in conformity.The valve appeared to meet the specifications required for a perceval valve model pvs s / 21.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.Based on the investigation performed, the reported event cannot be explained by any factor intrinsic to the returned device, as no malfunctions nor elements of non conformity were detected.As reported, the valve was not correctly positioned after the deployment (i.E.''it was visually confirmed that the valve was slightly tilted'').The root cause of the reported event of device malposition and subsequent paravalvular leak can be traced to the patient's peculiar anatomy (i.E.Bicuspid valve type 1) which led the surgeon to a change of surgical approach (use of the conventional valve).

• 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: 13182392
• MDR Text Key: 284978611
• Report Number: 3004478276-2022-00110
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)240218
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

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 Operator: Health Professional
• Device Expiration Date: 02/18/2024
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 01/06/2022
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2021
• 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: 71 YR
• Patient Sex: Female