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

Model Number PVF-XL

Device Problems Perivalvular Leak (1457); Malposition of Device (2616)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/27/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : the valve has been received and investigation is ongoing.

Event Description

On (b)(6) 2023, a perceval plus pvf-xl was attempted to be implanted in a patient.After implantation, a perivalvular leak was noted.As such, the valve was replaced with the valve with other model and size during the same day.No further information is available at this time.

Manufacturer Narrative

The manufacturing and material records for the perceval plus heart valve and stent, model # pvf-xl, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacture¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model # pvf-xl) perceval plus heart valve at the time of manufacture and release.Device has been returned to the manufacturer.After decontamination, the valve was visually inspected without observing any macroscopic anomalies and/or pre-existing defects according to the specifications.The replication of collapsing phases was performed using the returned valve pvf-s and a demo accessory kit, in order to attempt to reproduce the reported event.No problems were encountered in the collapsing phase, and the replication has been completed without problem.No problems were encountered during the deployment in silicon aortic roots #27, and the ballooning phase, and the sealing at the annulus level is guaranteed as visible in attached pictures thus, 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 the simulation.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 the relationship between the reported issue and the returned device quality.Furthermore, from the document review performed, no manufacturing defects were noted.Based on the medical judgment received, the cause of the reported event was related to mispositioning of the valve.Furthermore, it is reported that the valve was attempted to be re-collapsed.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.

Event Description

On (b)(6) 2023, a perceval plus pvf-xl was attempted to be implanted in a patient.After implantation, a perivalvular leak was noted.As such, the valve was replaced with the valve with other model and size during the same day.Based on the medical judgment received, the issue as not leak.The valve was originally mispositioned.As such, it was explanted and re-collapsed but prior to second implantation, a black wire was noted that did seem detached and surgeon did not know if this was normal, so the decision was made to implant an inspiris size 25 instead.

• Brand Name: PERCEVAL PLUS 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: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 18414798
• MDR Text Key: 331581651
• Report Number: 3004478276-2023-00221
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000825
• UDI-Public: (01)00896208000825(240)PVF-XL(17)240723
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011/S013
• 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: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVF-XL
• Device Catalogue Number: PVF-XL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2020
• 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: 72 YR
• Patient Sex: Male