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

Model Number PVS23

Device Problems Leak/Splash (1354); Malposition of Device (2616)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 05/08/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, a perceval valve size 23 was implanted in a patient.Reportedly, after de-clamp, pvl was noted on the right side of ncc of the valve.As such, the valve was explanted and replaced with inspiris valve 21mm.There were concomitant procedures for mvr, laa closure, and left atrium plication.No further information is available at this time.

Manufacturer Narrative

H3 other text: discarded by site.

Event Description

On (b)(6) 2023, a perceval valve size 23 was implanted in a patient.Reportedly, after de-clamp, moderate pvl was noted on the right side of ncc of the valve.As such, the valve was explanted and replaced with inspiris valve 21mm.There were concomitant procedures for mvr, laa closure, and left atrium plication.Based on the further information received, native valve was bicuspid type 1 (with r-n).Reportedly, mispositioning and positioning difficulty was noted during implant.Patient remained stable through the procedure.There was no impact on the patient and the outcome was good.Based on the medical judgement received, due to calcification of a/m continuity the valve did not sit well, or it is possible to that the valve was popped up after positioning.When the position was checked after clamped, there was a space between the ncc annulus and perceval that the forceps could pass through.

Manufacturer Narrative

Follow up report will be provided upon completion of review of production records.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model # icv1209, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a model # icv1209 perceval heart valve at the time of manufacture and release.Based on the information available.Malpositioning and positioning difficulty was noted during implant.Based on the medical judgment available, ''due to calcification, the valve did not sit well, or it is possible that the valve was popped up after positioning''.Furthermore, from the document review performed, no manufacturing deficiencies were noted with the device.As such, the cause of the event can reasonably be related to the malpositioning of the valve.Should further information be received in the future, a follow up report will be provided.

• 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
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 17072506
• MDR Text Key: 316670593
• Report Number: 3004478276-2023-00152
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)240917
• 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,Followup
• Report Date: 10/31/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 06/08/2023; 10/03/2023
• Supplement Dates FDA Received: 07/07/2023; 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2021
• 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
• Patient Age: 84 YR
• Patient Sex: Male