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

Model Number	PVF-S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed that on (b)(6) 2023, a patient was having a redo avr/cabg.The original prosthesis (unknown model, size 25) was explanted, and a complete debridement was performed.Then, sizing was started with the small sizer.The small sizer was falling through the annulus on the clear end and just barely catching on the opaque end.As such, they moved to medium sizer where the clear end was just barely catching, and the opaque end would not go through the annulus at all.As such, they went back and forth with the sizers 1 or 2 more times, and decided to proceed with size small perceval plus valve.Thus, collapsing was started while the surgeon began to place the guiding sutures.After the small valve was collapsed appropriately, deployment began.After the valve was deployed, checks were performed and ballooned with warm saline; and further checks were performed again.Surgeon stated that the guiding suture could be seen on the non-coronary cusp.It was recommended to take it out and re-implant, but this did not happen as they stated that it did not matter where the guiding suture was because it was a redo and as long as it was seated, they could make the annulus anywhere they wanted.While doing leak tests, it was noticed that the leaflets were slightly more open than normal, but the consensus was that the possible trace central leak would go away.At this point the valve was checked on echo quickly before completing the concomitant cabg.The long and short axis views looked good and did not show signs of leaks with the minimal volume in the heart.The surgeon then completed the procedure.After the clamp was off, it did not appear to be any issues.The left ventricle was not blowing up in size.However, when it got more volume, it showed a major central leak and had to go back on cross clamp to explant the perceval plus valve.It was then decided to implant a magna-ease valve instead and complete the procedure.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 18330146
• Report Number: 3019892983-2023-01023
• Device Sequence Number: 18001740
• Product Code: LWR
• UDI-Device Identifier: 00896208000795
• UDI-Public: (01)00896208000795(240)PVF-S(17)270202
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2023
• Report Date (Section F): 11/14/2023

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
• Operator of Device: Health Professional
• Device Model Number: PVF-S
• Device Catalogue Number: PVF-S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/14/2023
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/14/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown