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

Model Number PVS23

Device Problems Perivalvular Leak (1457); Device Dislodged or Dislocated (2923)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 03/17/2023

Event Type  Injury  

Event Description

The manufacturer was informed that on (b)(6) 2023, a perceval sutureless aortic heart valve size 23 was attempted to be implanted.Reportedly, a pvl was noted after the de-clamping.It was also suspected that inflow ring was partially dislodged from the valve.This perceval valve was explanted and a new pvs23 was implanted instead.Reportedly, the surgery was completed without problem.There was no impact on the patient and patient was stable through the delay in the surgery.

Manufacturer Narrative

Discarded by the site.

Event Description

The manufacturer was informed that on (b)(6) 2023, a perceval sutureless aortic heart valve, pvs23 was attempted to be implanted.Reportedly, a pvl was noted after the de-clamping.It was also suspected that inflow ring was partially dislodged from the valve.This perceval valve was explanted and a new pvs23 was implanted instead.Reportedly, the surgery was completed without problem.There was no impact on the patient and patient was stable through the delay in the surgery.Based on the medical judgement received, this event was not related to the valve.Reportedly, enough calcification was not removed from the annulus at the time of implant and the part of the annulus was protruded and inflow ring was popped out.The manufacturer was informed that no further information will be provided.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve and stent, 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 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 medical judgement received, this event was not related to the valve.Reportedly, enough calcification was not removed from the annulus at the time of implant and the part of the annulus was protruded and inflow ring was popped out.Furthermore, from the document review performed, no manufacturing deficiencies were noted.As such, unintended use error caused or contributed to the reported regurgitation event.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, bc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 16736836
• MDR Text Key: 313260309
• Report Number: 3004478276-2023-00140
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)250826
• 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: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• 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
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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: 73 YR
• Patient Sex: Female