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

Model Number	PVF-M
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/09/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The manufacturing and material records for the perceval plus heart valve, model # pvf-m, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a (model # pvf-m) perceval plus heart valve at the time of manufacture and release.Since limited information is available and the device was not returned, the manufacturer couldn't perform any further investigation on the event and the device involved.As such, no definitive root cause of the event could be established.It should be noted though that patient was in an advanced nyha class and had several comorbidities and risk factors which may have been instrumental in causing patient's death.Should further information be received in the future, the manufacturer will rivisit the case and take further actions as applicable.H3 other text : unknown disposition.
Event or Problem Description
The manufacturer was informed of the following event through mantra study database.Reportedly, a patient underwent an aortic heart valve replacement with perceval plus, size m on (b)(6) 2023.The surgical approach was a median sternotomy.A cabg procedure was performed before the valve implant with 1 vessel involved.Based on the information received, patient passed away on (b)(6) 2023 for unknown cause.The patient had missed previous appointments, including echocardiographic check and had experienced a cardiogenic shock on the same day of surgery, assessed by the site as not related to the device but probably related to implant procedure.The cardiogenic shock episode had been treated with medications and was resolved on (b)(6) 2023.As reported, the patient was in nyha class iii and clinical history included coronary artery disease, non-ischemic heart failure, systemic hypertension, diabetes mellitus type ii, non-insulin dependent, dyslipidemia, and lupus.

• 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
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 18379436
• Report Number: 3004478276-2023-00217
• Device Sequence Number: 15381686
• Product Code: LWR
• UDI-Device Identifier: 00896208000801
• UDI-Public: (01)00896208000801(240)PVF-M(17)260612
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P150011/S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2023

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 Expiration Date: 06/12/2026
• Device Model Number: PVF-M
• Device Catalogue Number: PVF-M
• Was Device Available for Evaluation?: No
• 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: 11/22/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2022
• 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: Death
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 65 KG