MAUDE Adverse Event Report: CORCYM CANADA CORP. VALVE AORTIC PERCEVAL XL 27 MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Patient Problems Failure of Implant (1924); Stenosis (2263); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/29/2016

Event Type  Injury  

Event Description

On date: (b)(6) 2016 patient's pre-operative diagnosis were as follow: 1- aortic stenosis (severe) 2- lv hypertrophy 3- high chads / has-bled score 4- small aortic aneurysm the following procedure was completed: 1- aortic valve replacement ( xl perceval sutureless pericardial) 2- epi-aortic ultrasound scanning 3- aortic root repair with commissural plication 4- exclusion of laa with 50mm atriclip no complications, patient tolerated the procedure well.On (b)(6) 2021, patient's required reintervention and pre-operative diagnosis was as follow.Severe perceval prosthetic aortic valve degeneration severe aortic valve stenosis sts score: 1.5% nyha class 3 chronic diastolic chf (congestive heart failure) the following procedure performed transfemoral transcatheter aortic valve replacement with edwards s3 # 26 valve (3 cc added into the balloon) cerebral protection: sentinel neuro embolic protection.No complications recorded.

• Brand Name: VALVE AORTIC PERCEVAL XL 27 MM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): CORCYM CANADA CORP.
• MDR Report Key: 17949578
• MDR Text Key: 326015017
• Report Number: MW5147014
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White