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

Model Number PVS23

Device Problem Incomplete Coaptation (2507)

Patient Problem Insufficient Information (4580)

Event Date 05/15/2023

Event Type  Injury  

Manufacturer Narrative

The device was returned to the manufacturer for further investigation.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 23/m 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; 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 the simulation.Considering the static conditions of the test, the water level remained stable under the leaflets free edge.The manufacturer is retrieving and reviewing the device production record and a follow up report will be provided upon completion of this review and/or receipt of any further information.

Event Description

On (b)(6) 2023, a perceval valve size 23 was attempted to be implanted.When the valve was implanted, the position was a little far from where it supposed to be.They tried to reposition the valve by forceps, but it was noted that the rcc leaflet of the valve was not working properly after de-clamped.As such, it was decided to implant another similar perceval valve size 23.It was mentioned that the leaflet of rcc was flat and that caused the limitation of its movement, but it is unknown why that happened.

Manufacturer Narrative

Updated fields: b4, b5, g3, g6, h2, h6.The manufacturer was informed that no further information will be provided.The manufacturer is retrieving and reviewing the device production record and a follow up report will be provided upon completion of this review.

Event Description

On (b)(6) 2023, a perceval valve size 23 was attempted to be implanted.When the valve was implanted, the position was a little far from where it supposed to be.They tried to reposition the valve by forceps, but it was noted that the rcc leaflet of the valve was not working properly after de-clamped.As such, it was decided to implant another similar perceval valve size 23.It was mentioned that the leaflet of rcc was flat and that caused the limitation of its movement, but it is unknown why that happened.Based on the further information received, patient's annulus was 22 mm.Concomitant procedure was cabg, which was performed before the implant, the procedure was full sternotomy.Reportedly, no central or paravalvular leak was noted and patient remained stable through the prolongation of surgery.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h6.The manufacturing and material records for the perceval heart valve, model #icv1209, s/n # (b)(6) as they pertain to the reported event, were retrieved and reviewed by a manufacture¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a (model #icv1209) perceval heart valve at the time of manufacture and release.Steady flow test review was also performed.The images demonstrated the acceptable opened and closed leaflet performance of the perceval pvs23 sn# (b)(6).No anomalies are observed during the open/close cycle.The valve therefore meets the acceptance criteria of the steady flow test inspection defined in dedicated procedure.Based on the information provided, the definitive root cause of the reported event cannot be established.However, based on the performed analyses, it is possible to exclude the relationship between the reported issue and the returned device quality since no problem was detected.Furthermore, from the document review performed.No manufacturing deficiencies were noted.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: 17111687
• MDR Text Key: 317041760
• Report Number: 3004478276-2023-00154
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)250209
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• 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: 05/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2022
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 37 KG