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

Model Number PVS23

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the perceval valve pvs23 was used for aortic valve replacement with concomitant procedures - mitral valvuloplasty, tricuspid annuloplasty and left atrial appendage closure.When the positioning of the perceval valve was checked visually, it was observed that the device dropped into the left ventricle side.The device was removed, then another perceval valve pvs23 was implanted, and the operation was completed without any problem.The patient had a good outcome.

• 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
• MDR Report Key: 13076985
• MDR Text Key: 282716165
• Report Number: 3019892983-2021-01057
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)240811
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2021,12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Distributor Facility Aware Date: 11/26/2021
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2021
• Date Manufacturer Received: 11/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention