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  

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209, s/n # (b)(4), including the nitinol stent component, 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.Since the device was not returned from the hospital, no further investigation is possible at this time.Based on the available information, it is not possible to draw a definitive conclusion to the reported event, however, from the document review performed, no manufacturing deficiencies were identified.Based on the manufacturer's experience, factors that may contribute to an intraoperative migration of the perceval valve can include manipulation of the heart and/or of the ascending aorta, a not correct positioning of the valve or a device mis-sizing.Given that the same size of the perceval valve was ultimately implanted, mis-sizing can be reasonably excluded.Ultimately, since the involved device is not available for return and no further information has been provided, a definitive root cause cannot be established at this time.The manufacturer is following up with the hospital to retrieve additional information, but no further details on the event have been provided to date.Should further information be received in the future, the manufacturer will provide a follow up report.

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.

Manufacturer Narrative

Based on the available information and medical judgment received, the root cause of the reported event was attributed to a mistake in the surgical procedure (use error).However, this aspect was not further specified.From the document review performed, no manufacturing deficiencies were identified.No adverse complications as a result of this event were reported for this patient, who had a good outcome.

Event Description

On (b)(6) 2021, the perceval valve pvs23 was used for aortic valve replacement with concomitant procedures (in order): mitral valvuloplasty, tricuspid annuloplasty and left atrial appendage closure.Then, the aortic valve replacement was performed.When the positioning of the perceval valve was checked visually, it was observed that the device dropped into the left ventricle side.The problem was detected immediately after the valve deployment, before the ballooning with the post-dilatation catheter.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.Based on the medical judgment received, the possible root cause of the reported event was attributed to a mistake in the surgical procedure.It was reported that no further decalcification was performed before the implant of the second perceval valve.

• 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
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 13077108
• MDR Text Key: 282719638
• Report Number: 3004478276-2021-00292
• 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: US
• 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,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 02/09/2022
• Supplement Dates FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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