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

Model Number PVS21

Device Problem Malposition of Device (2616)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 02/16/2023

Event Type  Injury  

Event Description

The manufacturer was informed that on (b)(6) 2023, a mics avr surgery using percival hear valve size s was performed and there was no concomitant procedure.Reportedly, after de-clamp during the surgery, moderate pvl was noted between rcc and lcc.As such, it was clamped again, and it was noticed that the position of the inflow ring was slightly above annulus.The device was explanted, and another percival valve size s was implanted instead.Reportedly, no leakage was noted after re-implantation, the surgical time was delayed about 60 minutes due to this event, patient remained stable through the prolongation of surgery, and the outcome of the patient was good.Based on the information received, patient's annulus was 28mm.Reportedly, positioning difficulty was noted during valve implantation.

Manufacturer Narrative

The manufacturing and material records for the percival heart valve and nitinol stent, model #icv1208, 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 #icv1208) percival heart valve at the time of manufacture and release.A follow up report will be provided upon receipt of the device or additional information.

Manufacturer Narrative

The valve was 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 pvs 21/s and a demo accessory kit.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 root #21, no problems was encountered during the ballooning phase: the sealing at the annulus level is guaranteed as visible in the attached pictures; thus, the valve remained fixed within the annulus.Then, inserting some water in the aortic root from the outflow side, no paravalvular leaks were observed during both the simulations.Considering the static conditions of the test, the water level remained stable under the leaflets free edge.Based on the performed analyses, the reported event cannot be explained by any factor intrinsic in the involved device.Furthermore, from the document review performed, no manufacturing deficiencies were noted.Based on the information available, it was noticed that the position of the inflow ring was slightly above annulus.As such, the cause of the reported event can be related to malpositioning.Should further information be received in the future, a follow up report will be provided.

• 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: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 16566988
• MDR Text Key: 311517615
• Report Number: 3004478276-2023-00121
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)250217
• 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: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2022
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 54 KG