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

Model Number PVS23

Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Abscess (1690); Aneurysm (1708); Endocarditis (1834)

Event Type  Injury  

Manufacturer Narrative

Unknow device disposition.

Event Description

This case refers to pt # 5 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 previously had two surgical interventions and was suffering from prosthetic valvular endocarditis (pve).A perceval pvs 23mm was implanted.After 24 months of implantation an echo showed the patient had signs of abscess and mycotic aneurysm.The patient required surgical intervention and a cabrol homograft was implanted.

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 2 previous surgical interventions.The patient developed pve 24 months after the implant of the pvs23 valve, leading to re-intervention.The microorganism was identified as staphylococcus aureus.The pre-operative tee showed abscess, with no vegetation and no periprosthetic leak.The pre-operative pet/ct scan showed mycotic aneurism.At the time of the re-intervention, the patient received a cabrol homograft and the patient survived.

Manufacturer Narrative

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: 12394907
• MDR Text Key: 273801426
• Report Number: 3004478276-2021-00207
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 10/13/2021
• Supplement Dates FDA Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR