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

Model Number TBD

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Chest Pain (1776)

Event Type  Injury  

Manufacturer Narrative

Since the device was not returned to the manufacturer and the serial number of the device is unknown, no further investigation on the device can be performed at this time.Based on the medical judgement received, the structural valve deterioration (svd) of perceval s was not related to any malfunction of the device itself.Reportedly, during redo-aortic and mitral valve replacement procedures, it has been found that the position of the mitral valve was interfered with the aortic position, which led to the deterioration of the aortic valve.As such, the valve can be excluded as a possible root cause of the reported event.Should further information be received in the future, a follow up report will be provided.Unknown device disposition.

Event Description

The manufacturer was informed of the following event through a published paper entitled, "left coronary ostial obstruction by a dislocated sutureless aortic valve prosthesis: redo aortic valve replacement with hybrid coronary revascularization: a case report," by seungmo yoo et al.Based on the information reported, a patient who underwent sutureless aortic valve replacement (avr) and mitral valve replacement (mvr) 4 years ago due to aortic and mitral valve stenosis visited the clinic for aggravated chest pain.Coronary angiography showed obstruction of the left main (lm) coronary ostium by a dislodged prosthetic aortic valve (perceval).In addition, there was collateral blood flow from the right coronary artery to the left anterior descending coronary artery.Computed tomography (ct) revealed that a dislodged prosthetic aortic valve had caused lm coronary artery ostium obstruction.On transthoracic echocardiography (tte), ventricular function was normal, and the function of both prosthetic valves was good.After a careful consideration of the patient¿s surgical risk, it was decided to perform redo avr and, if necessary, perform coronary artery bypass grafting (cabg).After the initiation of cardiopulmonary bypass (cpb) through cannulation on the femoral vessels, redo sternotomy and adhesiolysis were performed.Reportedly, the lm ostium was completely occluded due to the dislodged aortic prosthesis and resulting neointimal fibrous tissue ingrowth.The neointimal fibrous tissue was carefully peeled off, and the prosthesis was removed using the lasso technique.Lm endarterectomy was performed carefully, and cardioplegia was infused through the right coronary ostium to confirm patency.After confirming sufficient backflow from the left coronary ostium, conventional avr was performed.Postoperative tte showed no aortic regurgitation or paravalvular leakage.On postoperative day (pod) 6, percutaneous coronary intervention (pci) stenting was added for long-term patency.The patient was discharged on pod 9 without complications.As per medical judgment reported in the paper, based on the surgical findings, it is very likely that the sutureless valve, which was slightly staggered, fell off during the ballooning procedure.Therefore, the aorto-mitral curtain distance should be considered when performing sutureless avr in the setting of concomitant mitral valve surgery.Based on the further information and medical judgement received, the structural valve deterioration (svd) of perceval s was not related to any malfunction of the device itself.Reportedly, during redo-aortic and mitral valve replacement procedures, it has been found that the position of the mitral valve was interfered with the aortic position, which led to the deterioration of the aortic valve.

Manufacturer Narrative

Updated fields: b4, b5, g3, g6, h2, h6.Corrected fields: b5, h6.Based on the medical judgement received, the patient is suffering from chronic kidney disease and other chronic conditions and complications observed are not related to perceval valve itself.As such, the event cannot be traced to device.Should further information be received in the future, the manufacturer will provide a follow up report.

Event Description

The manufacturer was informed of the following event through a published paper entitled, "left coronary ostial obstruction by a dislocated sutureless aortic valve prosthesis: redo aortic valve replacement with hybrid coronary revascularization: a case report," by seungmo yoo et al.Based on the information reported, a patient who underwent sutureless aortic valve replacement (avr) and mitral valve replacement (mvr) 4 years ago due to aortic and mitral valve stenosis visited the clinic for aggravated chest pain.Coronary angiography showed obstruction of the left main (lm) coronary ostium by a dislodged prosthetic aortic valve (perceval).In addition, there was collateral blood flow from the right coronary artery to the left anterior descending coronary artery.Computed tomography (ct) revealed that a dislodged prosthetic aortic valve had caused lm coronary artery ostium obstruction.On transthoracic echocardiography (tte), ventricular function was normal, and the function of both prosthetic valves was good.After a careful consideration of the patient¿s surgical risk, it was decided to perform redo avr and, if necessary, perform coronary artery bypass grafting (cabg).After the initiation of cardiopulmonary bypass (cpb) through cannulation on the femoral vessels, redo sternotomy and adhesiolysis were performed.Reportedly, the lm ostium was completely occluded due to the dislodged aortic prosthesis and resulting neointimal fibrous tissue ingrowth.The neointimal fibrous tissue was carefully peeled off, and the prosthesis was removed using the lasso technique.Lm endarterectomy was performed carefully, and cardioplegia was infused through the right coronary ostium to confirm patency.After confirming sufficient backflow from the left coronary ostium, conventional avr was performed.Postoperative tte showed no aortic regurgitation or paravalvular leakage.On postoperative day (pod) 6, percutaneous coronary intervention (pci) stenting was added for long-term patency.The patient was discharged on pod 9 without complications.As per medical judgment reported in the paper, based on the surgical findings, it is very likely that the sutureless valve, which was slightly staggered, fell off during the ballooning procedure.Therefore, the aorto-mitral curtain distance should be considered when performing sutureless avr in the setting of concomitant mitral valve surgery.Based on the further information and medical judgement received, the patient is suffering from chronic kidney disease and other chronic conditions and complications observed are not related to perceval valve itself.Furthermore, adverse patient effects were reported from hospital.

Event Description

The manufacturer was informed of the following event through a published paper entitled, "left coronary ostial obstruction by a dislocated sutureless aortic valve prosthesis: redo aortic valve replacement with hybrid coronary revascularization: a case report," by seungmo yoo et al.Based on the information reported, a patient who underwent sutureless aortic valve replacement (avr) and mitral valve replacement (mvr) 4 years ago due to aortic and mitral valve stenosis visited the clinic for aggravated chest pain.Coronary angiography showed obstruction of the left main (lm) coronary ostium by a dislodged prosthetic aortic valve (perceval).In addition, there was collateral blood flow from the right coronary artery to the left anterior descending coronary artery.Computed tomography (ct) revealed that a dislodged prosthetic aortic valve had caused lm coronary artery ostium obstruction.On transthoracic echocardiography (tte), ventricular function was normal, and the function of both prosthetic valves was good.After a careful consideration of the patient¿s surgical risk, it was decided to perform redo avr and, if necessary, perform coronary artery bypass grafting (cabg).After the initiation of cardiopulmonary bypass (cpb) through cannulation on the femoral vessels, redo sternotomy and adhesiolysis were performed.Reportedly, the lm ostium was completely occluded due to the dislodged aortic prosthesis and resulting neointimal fibrous tissue ingrowth.The neointimal fibrous tissue was carefully peeled off, and the prosthesis was removed using the lasso technique.Lm endarterectomy was performed carefully, and cardioplegia was infused through the right coronary ostium to confirm patency.After confirming sufficient backflow from the left coronary ostium, conventional avr was performed.Postoperative tte showed no aortic regurgitation or paravalvular leakage.On postoperative day (pod) 6, percutaneous coronary intervention (pci) stenting was added for long-term patency.The patient was discharged on pod 9 without complications.As per medical judgment reported in the paper, based on the surgical findings, it is very likely that the sutureless valve, which was slightly staggered, fell off during the ballooning procedure.Therefore, the aorto-mitral curtain distance should be considered when performing sutureless avr in the setting of concomitant mitral valve surgery.Based on the further information and medical judgement received, the patient is suffering from chronic kidney disease and other chronic conditions and complications observed are not related to perceval valve itself.Furthermore, adverse patient effects was reported from hospital.Based on the medical judgment received, it was impossible to prevent dislodgement due to the patient's condition.

Manufacturer Narrative

Updated fields: b4, b5, g3, g6, h2, h6.Based on the medical judgement received, the patient was suffering from chronic kidney disease and other chronic conditions and complications observed are not related to perceval valve itself.Furthermore, it was mentioned that it was impossible to prevent dislodgement due to the patient's condition.As such, the cause of the event was related to patient condition.

• 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: 16685537
• MDR Text Key: 312759462
• Report Number: 3004478276-2023-00134
• Device Sequence Number: 1
• Product Code: LWR
• 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: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2023
• 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: 82 YR
• Patient Sex: Female