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

Model Number PVS

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Heart Block (4444)

Event Type  Injury  

Event Description

Received the information from a published paper "use of sutureless valve in aortic root enlargement" by silvana f.Marasco.Based on the information provided in this paper, perceval valve was implanted in the patients with small annulus after performing a root enlargement.As reported, result of the study post-operative course was unremarkable in all patients except for the patient who had a double valve replacement and required a permanent pacemaker insertion on day 5 post-operatively for a complete heart block.Follow-up (median 2 years, range 1 month to 4 years), has shown no paravalvular leak in any of the patients and transvalvular pressure gradients remained low (12 mmhg¿21 mmhg) at the latest follow-up.No further information is available at this time.

Manufacturer Narrative

H3 other text : device remained implanted.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h6.Manufacturer attempted to follow up with author, but no further information has yet been received despite manufacturer multiple attempts of follow up.Since limited information is available, the definitive root cause of the reported event could not be established at this time.Conduction disorders are common in patients with aortic valve diseases.As a result, it is common for patients to receive permanent pacemaker implantation after aortic valve replacement.Risk factors include preexisting conducting disease and preoperative aortic regurgitation.This event is, therefore, a known, inherent risk of the procedure, and it is listed among the potential adverse events in the perceval ifu.

• 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 V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 18744236
• MDR Text Key: 335813381
• Report Number: 3004478276-2024-00114
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PVS
• Device Catalogue Number: TBD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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