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

Model Number PVS

Device Problems Leak/Splash (1354); Perivalvular Leak (1457)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/17/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a perceval valve pvs 21 was attempted to be implanted.The valve was implanted without problems with collapsing.After declamping, during the echo both a central and a pv leak (intermediate position between lcc and ncc) were observed.Th patient was cross-clamped again, the surgeon fine-tuned the valve, and confirmed the correct position and declamped after ballooning at 7 atm.No improvement in the leak was observed via the echo.The patient was cross-clamped one more time and the valve was explanted.Resizing was performed and another pvs 21 size was selected.A new s size valve was collapsed and implanted and a second echo confirmed there were no leaks.The extended cross clamp time was 128 minutes.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby V5J 5 M1; CA V5J 5M1
• MDR Report Key: 12480549
• MDR Text Key: 271673090
• Report Number: 1718850-2021-01204
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)230610
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2021,09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2023
• Device Model Number: PVS
• Device Catalogue Number: PVS21
• Device Lot Number: A98151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 42