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

Model Number PVS23

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Endocarditis (1834)

Event Type  Injury  

Manufacturer Narrative

Unknown device disposition.

Event Description

This case refers to pt # 10 of 14 : based on information received from the paper "endocarditis on a perceval s sutureless prosthesis.A new valve with a new form of clinical presentation" by m.V.Groba-marco.The patient was suffering from prosthetic valvular endocarditis (pve).A perceval pvs 23 mm was implanted.After 10 months of implantation an echo was performed which showed an aortic thickening and abscess.The patient underwent surgical treatment and a new perceval valve 23 mm and a patch were implanted.30 months later the patient died.

Event Description

The manufacturer was informed on this event through the publication "endocarditis on a perceval s sutureless prosthesis.A new valve with a new form of clinical presentation" by groba-marco et al.Based on the information reported in the paper, infectious endocarditis is a disease with high morbidity and mortality, the most severe form being prosthetic valvular endocarditis (pve).The authors of the paper performed a retrospective observational study to analyze the prevalence and presenting characteristics of pve in the perceval prosthesis, with particular attention paid to diagnostic imaging.Since 2015, 670 perceval s valves have been implanted and 14 cases of pve have been diagnosed in them.This case refers to a patient who received a perceval pvs23 valve.The patient had one previous surgical intervention.The patient developed pve 7 months after the implant of the pvs23 valve, leading to re-intervention.The microorganism was identified as coagulase-negative staphylococcus.The pre-operative tee showed ic mitro-aortic thickening, with no vegetation and no periprosthetic leak.The pet/ct scan showed coronary abscess.At the time of the re-intervention, a new perceval valve pvs23 was implanted after patching the aortic annulus with bovine pericardium.The patient ultimately passed away after 30 months (submitted separately).

Manufacturer Narrative

G3, g6, h1 (corrected, the manufacturer submitted a separate report to capture the patient's death with the second perceval valve implanted).The manufacturer attempted to retrieve additional information on the reported event.However, no further details have been received to date.Since the device serial number is unknown and its disposition is unknown (device not returned to the manufacturer), no further investigation is possible at this time.Based on the limited information available, it is not possible to establish a definitive root cause for the reported event.It should be noted that endocarditis is listed as a possible adverse event in the perceval ifu.The event is, therefore, a known inherent risk of the device.As no further investigation is possible, the manufacturer will proceed with the case closure at this time.Should the manufacturer receive additional information in the future, an update to this reporting activity 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
• MDR Report Key: 12394550
• MDR Text Key: 269020395
• Report Number: 3004478276-2021-00203
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 62 YR