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); Thrombocytopenia (4431); Heart Failure/Congestive Heart Failure (4446)

Event Date 07/06/2021

Event Type  Injury  

Event Description

The manufacturer was informed of the following event through report (ref.Mw5147012) from fda.On (b)(6) 2017, patient had pre-operative diagnosis: 1- aortic stenosis (severe) 2- lv hypertrophy 3-reduced lv function (ef 50%) 4- renal failure (stage 3) with following operation 1- minimally invasive aortic valve replacement (xl perceval pericardial heart valve) via right anterior mini-thoracotomy 2- rigid titanium plate for third rib fixation.Patient tolerated procedure well.Since patient was diagnosed with severe prostatic aortic valve stenosis, acute on chronic diastolic heart failure, hepatitis c chronic kidney disease stage iii, thrombocytopenia suspected liver cirrhosis, mean aortic gradient of the prostatic valve was 72 mmhg, reintervention (tavr) was performed on 6 july 2021.Mortality score is 14.3% high risk.Operative procedure included urgent transfemoral transcatheter aortic valve replacement with a 26 mm edwards sapient s3 valve, deployment of the s3 valve into the degenerated xl perceval valve central cerebral embolic protection, large sheath 14 french left common femoral artery, pigtail catheter 5 french right common femoral artery, temporary pacemaker access site left common femoral vein, and 6 french sheath per md records.Reportedly, patient tolerated procedure well and was returned to recovery in stable condition.No further information is available at this time.

• 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
• MDR Report Key: 18234449
• MDR Text Key: 329317667
• Report Number: 3019892983-2023-01021
• 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: Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/11/2023,11/29/2023

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 Operator: Health Professional
• 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?: Yes
• Date Report Sent to FDA: 10/11/2023
• Distributor Facility Aware Date: 10/31/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2023
• Date Manufacturer Received: 10/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention