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

Model Number PVS

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/16/2024

Event Type  Injury  

Manufacturer Narrative

H3 other text : unknown disposition.

Event Description

Manufacturer was informed that a perceval valve (unknown model) was implanted in the patient on unknown date.Reportedly, the valve was scheduled to be explanted on 1(b)(6) 2024.No further information is available at this time.

Manufacturer Narrative

Manufacturer attempted to retrieve further information regarding the event and the device involved but no further information was provided despite manufacturer's multiple attempts of follow up.Since limited information is available, further investigation on the device could not be performed and the definitive root cause of the reported event could not be established at this time.Should further information be received in the future, manufacturer will re-visit the case and take further actions as applicable.

• 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: 18890761
• MDR Text Key: 337511339
• Report Number: 3004478276-2024-00122
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS
• Device Catalogue Number: TBD
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2024
• 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