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

Model Number	PVF-L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, perceval plus size l was attempted to be implanted.Reportedly, the device was collapsed with relyon system without any issues.Guiding sutures were placed in eyelets and valve was deployed into place without issue.Position of the valve was inspected, and no issues were detected.Thus, the valve was ballooned for 30s at 4 atm¿s.Then, aorta was closed, and they began to perform the cabg.Once cabg was performed clamp was removed, and the refill process was started.Patient required 2-3 shocks to get a rhythm.They de-aired with a 19ga needle.No leaks or ar was observed in the echo.All of the sudden surgeon called for a ballon pump and the ballon pump was inserted into the patient's rt groin.At this point, significant regurgitation was noted.The reason for this regurgitation was unknown since before inserting the pump, no leakage was present.As such, they decided to re-clamp and replace the perceval with a 23 mm inspiris valve.Based on the further information received, no malfunction with the device was noted, and patient's outcome was good.Reportedly, annulus was measured as 22.0mm, stj was 25.6, and ratio was 1.16.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC 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: 19581187
• Report Number: 3019892983-2024-01009
• Device Sequence Number: 3340534
• Product Code: LWR
• UDI-Device Identifier: 00896208000818
• UDI-Public: (01)00896208000818(240)PVF-L(17)270309
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2024
• Report Date (Section F): 05/21/2024

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-L
• Device Catalogue Number: PVF-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/21/2024
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2024
• 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 Age: 79 YR
• Patient Sex: Male