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

Model Number PVS23

Device Problem Incomplete Coaptation (2507)

Patient Problems Aortic Valve Insufficiency/ Regurgitation (4450); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

H3 other text : valve remains implanted.

Event Description

A perceval valve size 23 was implanted in a patient on 04 sep 2023.It was noted by echo that 2 of the leaflets of the valve were not working.Based on the information received, the type of re-intervention that going to be performed is still unknown.No further information is available at this time.

Event Description

A perceval valve size 23 was implanted in a patient with stenotic native valve on (b)(6) 2023 through full sternotomy.It was noted by echo that 2 of the leaflets of the valve were not working.Based on the further information received, no leak was noted, and there is still no plan for the re-intervention to be performed.Reportedly, patient was discharged from hospital after thrombolysis with heparin therapy.Cabg, laac, tap was performed concomitantly before perceval implant.Annulus size was about 23.4 mm.Reportedly, no problem was noted in tee and tte, no malposition, and mis-sizing were noted.Furthermore, there was no abnormal geometries in patient's anatomy.

Manufacturer Narrative

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 the manufacturer¿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# b23801.No anomalies were observed during the open/close cycle.The valve therefore meets the acceptance criteria of the steady flow test inspection defined in dedicated procedure at the time of release.Based on the limited information available, the definitive root cause of the reported event cannot be established.Hower, from the document review performed, no manufacturing deficiencies were noted.It should be noted that no re-intervention has planned to be performed yet at this time and patient has been discharged after anticoagulation therapy.As such, no further investigation is possible, and cause of the event cannot be established at this time.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: 17954302
• MDR Text Key: 325937439
• Report Number: 3004478276-2023-00185
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)251102
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• 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): Other