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

Model Number TBD

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

Patient Problems Chest Pain (1776); Vascular Dissection (3160); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/20/2022

Event Type  Injury  

Manufacturer Narrative

Since the device was not returned to the manufacturer for analysis and the serial number remains unknown, the manufacturer couldn't perform any further investigation on the prosthesis involved in this event.Although the manufacturer couldn't perform a direct analysis of the device involved in the reported event or a review of its manufacturing records, based on the information retrieved the root cause of the reported event can be reasonably traced to off-label use of the perceval valve.In fact, according to the perceval valve ifus, the use of the perceval prosthesis is contraindicated in subjects with aneurysmal dilation of the ascending aortic wall.The manufacturer will close the case at this time and submit a follow up report in case any new information will become available in the future.

Event Description

The manufacturer was informed through a publication (ref.Sonaglioni et al., j cardiovasc echogr.2023 apr-jun;33(2):98-101.) of a perceval sutureless aortic valve explant occurred after 4 years from implant due to aortic dissection.The patient had a history of dyslipidemia, dysthyroidism, bronchial asthma, and was implanted in 2018 at a different facility, with a size l perceval bioprosthesis due to degenerative aortic valve disease.As per additional information received, the patient was diagnosed with a 40 mm aneurysm of the ascending aorta at the time of implant and the prosthesis was normo-functioning at several follow up checks post-implant.Reportedly, the patient presented to the emergency department due to chest pain radiating up into the neck lasting for about 2 hours.At the echo check performed (2d tte) the perceval valve was found to be well-positioned in the aortic root with normal hemodynamics (mean transprosthetic pressure gradient of 11 mmhg) and mild intraprosthetic regurgitation.An echocardiographic image of double binary limited to the tubular ascending aorta, not involving the aortic arch, suspected for aortic dissection, was detected.The left ventricle had moderate hypertrophy, normal end-diastolic dimensions and normal ejection fraction (65%).A first degree of left ventricular diastolic dysfunction was present and the left atrium was slightly dilated.The right heart chambers' sizes were normal.In addition, a mild-to-moderate mitral and tricuspid valve regurgitation was diagnosed.It was reported that pericardial effusion was absent.Tee and subsequent contrast-enhanced ct confirmed ascending aorta dissection (stanford type a/type ii debakey).According to medical judgement, the aortic lesion was likely caused by the repeated mechanical stretch exerted by the stent struts against the aortic intima during the cardiac cycle, since the intimal tear was found to be near the free margin of the perceval prosthesis stent.In addition, a temporary rise in blood pressure might have contributed to the ascending aorta wall dissection.The patient was treated on (b)(6) 2022 in emergency with surgical remotion of perceval sutureless valve and ascending aorta, replaced with dacron graft prosthesis 26 (bentall procedure) and an aortic valve from a different manufacturer (edwards lifesciences magna ease perimount 23), with optimal surgical result.Reportedly, after surgical intervention, the patient underwent multiple blood transfusions and the postoperative course was complicated by episodes of paroxysmal atrial fibrillation, treated with intravenous amiodarone.During the second postoperative week, the patient reported the sudden onset of left hemiplegia, dysarthria, and dysphagia, due to a right frontoparietal ischemic stroke.Ct scan of the brain showed the acute ischemic lesion with mild hemorrhagic infarction, treated with medications.The patient was thus transferred to the division of neuromotor where he developed covid-19 infection in absence of pneumonia, successfully controlled with medical therapy.The patient was discharged after 2 months, and transferred to a long-term care facility.

• 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
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 18099405
• MDR Text Key: 327699322
• Report Number: 3004478276-2023-00195
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TBD
• Device Catalogue Number: TBD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 83 YR
• Patient Sex: Male