MAUDE Adverse Event Report: CORCYM CANADA CORP. PERCEVAL PLUS SUTRUELESS 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	02/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : unknown disposition.
Event or Problem Description
On (b)(6) 2024, a perceval plus valve pvf-s was attempted to be implanted as follows: patient presented with severe aortic stenosis.Annulus measurement of 21.4, stj of 26.5-27.4 via tee.The usual aortotomy was conducted as well as debridement of the calcium.Sizing was conducted.Clear end of a small sizer fell through, white passed with little resistance.After the small valve was implanted, they were unable to get pressures up above 79mm and seeing a small central leak on tee.As such, it was decided to recess the valve to swap for a sutured valve.As reported, upon opening and perceval removal, there was some additional calcium present on the annulus.
Additional Manufacturer Narrative
The manufacturing and material records for the device involved in this event, as they pertain to the reported issue, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this prosthesis satisfied all required material, visual, and performance standards at the time of manufacture and release.Based on the information received, upon perceval removal, there was some additional calcium present on the annulus.Furthermore, from the document review performed, no manufacturing deficiencies were noted.As such, the event can reasonably be related to not complete decalcification of annulus (use error).Should further information be received in the future, a follow up report will be provided.
Event or Problem Description
On (b)(6) 2024, a perceval plus valve pvf-s was attempted to be implanted as follows: patient presented with severe aortic stenosis.Annulus measurement of 21.4, stj of 26.5-27.4 via tee.The usual aortotomy was conducted as well as debridement of the calcium.Sizing was conducted.Clear end of a small sizer fell through, white passed with little resistance.After the small valve was implanted, they were unable to get pressures up above 79mm and seeing a small central leak on tee.As such, it was decided to recess the valve to swap for a sutured valve.As reported, upon opening and perceval removal, there was some additional calcium present on the annulus.Based on the further information received, patient was extremely well throughout the procedure and continues to do well.

• Brand Name: PERCEVAL PLUS SUTRUELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 18937898
• Report Number: 3004478276-2024-00126
• Device Sequence Number: 17864081
• Product Code: LWR
• UDI-Device Identifier: 00896208000795
• UDI-Public: (01)00896208000795(240)PVF-S(17)270113
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P150011/S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown