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

Model Number PVS27

Device Problem Degraded (1153)

Patient Problems Aortic Valve Stenosis (1717); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

H3 other text : tavr performed, not explanted.

Event Description

The manufacturer was informed of the following event through report (ref.Mw5147014) from fda.Based on the information available, patient originally was diagnosed with 1- aortic stenosis (severe) 2- lv hypertrophy 3- high chads / has-bled score 4- small aortic aneurysm.As such, aortic valve replacement with xl perceval sutureless pericardial, epi-aortic ultrasound scanning, aortic root repair with commissural plication, and exclusion of laa with 50mm atriclip was performed on (b)(6) 2016 with no complications.Reportedly, patient tolerated the procedure well.On (b)(6) 2021, re-intervention was required since patient was diagnosed with 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 were reported.No further information is available.

• 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: 18234549
• MDR Text Key: 329318588
• Report Number: 3004478276-2023-00206
• 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: Other,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2023
• 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