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

Model Number PVS23

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 08/18/2021

Event Type  Injury  

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a model #icv1209 perceval heart valve at the time of manufacture and release.Based on the information available and medical judgment received, the root cause of the reported event can be traced to an intraoperative mis-sizing (use error).No device malfunctions occurred and no adverse event/serious injury for the patient occurred.As such, no further investigation is warranted at this time.

Event Description

The manufacturer was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, a perceval valve pvs23 was implanted and explanted on the same day on (b)(6) 2021.Another perceval valve pvs25 was finally implanted.The manufacturer did not receive any allegation of a device malfunction nor of a serious injury from the site regarding this event.Based on the additional information received, the patient underwent a mitral valve repair, aortic valve replacement, atriclip left auricular appendage.After the pvs23 valve implant, on separating from bypass, there was echocardiographic evidence of valve undersizing of the aortic valve.A short additional cross clamp bypass run therefore undertaken and a perceval pvs25 was ultimately implanted.Per medical judgment received, the pvs23 valve was explanted intraoperatively due to incorrect initial size and there was no device malfunction identified.The patient had a good outcome.The explanted device is retained by the site.

• 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: 12602569
• MDR Text Key: 278153134
• Report Number: 3019892983-2021-01021
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)210923
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2021,10/09/2021

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 Expiration Date: 09/23/2021
• 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: 09/10/2021
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2021
• Date Device Manufactured: 09/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR