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

Model Number PVS23

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 09/20/2021

Event Type  Injury  

Manufacturer Narrative

Since the device was discarded and the serial number was not provided, no further investigation can be performed at this time.However, based on the medical judgment received, the root cause of the reported event can be attributed to a device mis-sizing (use error).No device malfunctions nor problems were identified.As such, no further investigation is warranted at this time.

Event Description

In (b)(6) 2021, a perceval valve size m was implanted in a patient.The surgery went well, a small central leak was detected.During (b)(6) 2021, the central leak became significant and associated with a paravalvular leak.The ct images showed that the valve was tilted on the annulus and also that the stj measured at 29 mm.A re-operation was performed on (b)(6) 2021.The perceval valve was explanted it was replaced with hancock 23.Based on the medical judgment received, the root cause was attributed to a clear valve undersizing.There was no problem nor malfunction noted with the perceval valve in question.The patient is doing very well.No further information will be provided on this case.

Manufacturer Narrative

Corrected f10 - medical device code.This field has been corrected to reflect properly the event mode (device malposition and perivalvular leak).The remainder of the information previously submitted remains unchanged.

• 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: 12586391
• MDR Text Key: 278153588
• Report Number: 3019892983-2021-01009
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 09/21/2021,10/06/2021

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
• Distributor Facility Aware Date: 09/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR