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

Model Number PVS23

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/31/2022

Event Type  Injury  

Event Description

The manufacturer was informed that on (b)(6) 2022, a pvs23 was attempted to be implanted, but leak occurred.As such, the pvs valve was explanted and inspiris valve was implanted instead.No further information is available at this time.

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.The manufacturer is following up to retrieve further information regarding the event and device involved.A follow up report will be provided upon receipt of further information.The device will not be returned by site.

Event Description

The manufacturer was informed that on (b)(6) 2022, a pvs23 was attempted to be implanted, but leak occurred.As such, the pvs valve was explanted and inspiris valve size 21 was implanted instead.Based on the further information received, the concomitant procedure was cabg.The patient had infection, and the product was discarded at the hospital.Based on the medical judgment received, the device relationship to the event was ¿probably not related".Furthermore, patient valve was type 0 bicuspid and perceval could not be implemented as it was supposed to be.Reportedly, about 30 min was added to the cross-clamp time and bypass time, patient remained stable through the procedure, there was no impact on the patient, and outcome was good.

Manufacturer Narrative

Based on the medical judgment received, there was probably no relationship between the device and the reported event.Furthermore, it was mentioned that the patient valve was type 0 bicuspid and perceval could not be implemented as it was supposed to be.As such, cause of the event was reasonably attributed to the patient's anatomy.H3 other text : device was discarded at the hospital.

• 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: roberta lamberti ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 15505317
• MDR Text Key: 300806963
• Report Number: 3004478276-2022-00190
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)241125
• 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: 03/03/2023

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: 09/01/2022
• Initial Date FDA Received: 09/29/2022
• Supplement Dates Manufacturer Received: 02/02/2023
• Supplement Dates FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2021
• 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: 64 YR
• Patient Sex: Female