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

Model Number PVS23

Device Problem Positioning Failure (1158)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/23/2022

Event Type  Injury  

Event Description

The manufacturer was informed of implant and intra-operative explant of a perceval sutureless aortic heart valve, pvs23 on (b)(6) 2022.Based on the information received, the preoperative ultrasound diagnosis was aortic stenosis and a small valve ring.The height from the aortic valve ring to stj was small, so a bicuspid aortic valve malformation was suspected.After opening the heart, it was confirmed that the aortic valve was a bilobal valve (between type 0 and type 1).After sizing, size m was determined as the appropriate size, then guiding sutures were deployed, valve was collapsed and released, balloon expansion was performed, and 37 warm saline was infused into the aortic root.After observation, the aorta was sutured.Patient heart was re-beat.Then, using tte it was observed that the valve was malpositioned and accompanied by severe perivalvular leakage.Then explanted and re-implanted per the normal process.However, there was still a lot of perivalvular leakage via tte test, and the implanting performance was still unsatisfactory.This operation was repeated three times and the results were the same.Considering that the patient was on the cardiopulmonary machine for too long, from the perspective of patient safety, another mechanical valve (medtronic ap360, size 20) was ultimately used to complete the procedure.As reported, patient was in good condition and transferred to the intensive care unit.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209, s/n # (b)(4), 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 #icv1209) perceval heart valve at the time of manufacture and release.The valve was returned to the manufacturer.The visual inspection performed on the returned prosthesis confirmed the absence of pre-existing defects.The collapsing procedure performed with the returned valve and a demo accessory kit was completed with no issue.During the simulation of the valve deployment in silicon aortic roots #21 and #23 and no problems were encountered during the ballooning phase.The sealing at the annulus level was guaranteed and the valve remained fixed within the annulus.Then, inserting some water in the aortic roots from the outflow side, no paravalvular leaks were observed during both simulations, considering the static conditions of the test.The water level remained stable under the leaflets free edge.Based on the performed analyses, it is possible to exclude any relationship between the device and the reported issue.Furthermore, from the document review performed, no manufacturing deficiencies were identified.Based on the medical judgement received "using tte it was observed that the valve was malposition and accompanied by severe perivalvular leakage.", the root cause of the observed perivalvular leak could be reasonably related to the mispositioning of the device.

• 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 V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: roberta lamberti ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 15481441
• MDR Text Key: 300585790
• Report Number: 3004478276-2022-00188
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)251020
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• 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 Sex: Female