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

Model Number	PVF-L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed that on (b)(6) 2023, a perceval plus valve size l was attempted to be implanted in a patient.Reportedly, when they went off pump, there was no heartbeat.As such, they went back on pump, explanted the valve and replaced it with intuitive 23mm valve.However, off pump there was still no heartbeat.Thus, the patient was air flighted to another facility.No further information is available at this time.

• 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 V5J 5 M1; CA V5J 5M1
• MDR Report Key: 18136621
• Report Number: 3019892983-2023-01020
• Device Sequence Number: 20828778
• Product Code: LWR
• UDI-Device Identifier: 00896208000818
• UDI-Public: (01)00896208000818(240)PVF-L(17)270406
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/14/2023
• Report Date (Section F): 10/17/2023

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-L
• Device Catalogue Number: PVF-L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/17/2023
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2023
• 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: Male