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

Model Number PVS25

Device Problems Perivalvular Leak (1457); Device Dislodged or Dislocated (2923)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 09/24/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a perceval valve pvs25 was attempted to be implanted.The patient's baseline conditions showed calcium on the septum site, native trileaflet valve, stj normal, normal annulus dimension.A thorough decalcification was reportedly performed.The implantation went very well, a good positioning of the valve was confirmed after inspection and no annulus could be seen.After the implant, on the echo a serious perivalvular leak (pvl) was detected.The echo showed that the valve was pushed up on the non coronary cusp.No stent folding was identified.The valve was consequently explanted and attempted to be re-collapsed, unsuccessfully.Ultimately, the patient received a new perceval valve pvs25.Despite the prolongation of the cross clamp time, the patient remained stable during the procedure with no adverse consequences reported.Based on the surgeon's assessment, no possible root cause for the pvl was identified.As reported, during implantation the valve was positioned in a good way.The valve was inspected thoroughly after implantation and no abnormalities were identified.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1210, s/n # (b)(6), including the nitinol stent component, 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 #icv1210) perceval heart valve at the time of manufacture and release.The device was returned to the manufacturer and it was received on november 03, 2021.Further investigation is ongoing and a follow up report will be provided upon completion of the investigation.

Manufacturer Narrative

After decontamination, the valve was visually inspected without observing any macroscopic anomalies and/or pre-existing defects according to the specifications.The height of each leaflet has been verified by means the specific tool and it resulted in conformity.The dimensional analysis confirmed the correct dimensions of the returned device.In order to attempt to reproduce the reported event, a simulation of the collapsing phases and of deployment have been reported.The collapsing simulation was performed using the returned valve pvs 25/l and the returned accessories part of the accessory kit l lot# 2006110125.No problems were encountered in the collapsing phase, and the replication has been completed with a good result.During the simulation of the valve deployment in silicon aortic roots #25 and #23, no problems were encountered during the ballooning phase: the sealing at the annulus level is 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 the simulations.Considering the static conditions of the test and despite the residual deformation observed at the inflow side level, the water level remained stable under the leaflets free edge.Based on the performed analyses, it is possible to exclude the relationship between the reported issue and the returned device quality.No problems were detected in the returned device.Based on the manufacturer's experience with similar cases, intraoperative events of perivalvular leak may be caused by a device mis-sizing or device malpositioning.Given that a new perceval valve of the same size was ultimately implanted, the mis-sizing can be reasonably excluded as root cause of this event.As reported, the echo showed that the ''valve was pushed up on the non coronary cusp''.It is possible that the valve may have not been correctly positioned at the time of implant, thus leading to the tilting and subsequent perivalvular leak.Ultimately, since this was not confirmed by the medical judgment received, the root cause remains unknow at this time.As explained in the perceval instructions for use, ''a removed perceval prosthesis must not be re-implanted, because its integrity is no longer ensured.'' as such, the decision to re-collapse the valve was made off-label.

• 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: 12668655
• MDR Text Key: 281983744
• Report Number: 3004478276-2021-00268
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)240129
• 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,Followup
• Report Date: 12/23/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2024
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 10/27/2021; 12/02/2021
• Supplement Dates FDA Received: 11/25/2021; 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2020
• 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: 74 YR
• Patient Sex: Male