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

Model Number	PVF-L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/28/2023
Type of Reportable Event	Death
Event or Problem Description
The manufacturer was informed of the following event through mantra study database.Reportedly, a perceval plus valve size l was implanted in the patient on (b)(6)2023.Based on information received, patient had hemorrhagic shock- cardiac arrest on (b)(6) 2023.The patient went into pea during egd - hypotension and anesthesia, acute respiratory failure and intubated at the time of code.The patient underwent diagnostic tests and transfusion, but eventually passed away on (b)(6) 2023.As reported, the patient's clinical history included coronary artery disease; arrhythmia: atrial fibrillation; cardiac conduction disorder: rbbb; systemic hypertension; and dyslipidemia.Furthermore, patient went under atrial fibrillation treatment in 2003, and was nyha class ii.
Additional Manufacturer Narrative
H3 other text : no indication of device explant.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval plus heart valve and stent, model # pvf-l-us, 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-l-us perceval plus heart valve at the time of manufacture and release.Since further investigation on the device could not be performed, and limited information is available regarding the cause of hemorrhage, definitive root cause of the reported event cannot be established.However, from the document review performed, no manufacturing deficiencies were noted.Should further information be received in the future, a follow up report will be provided.

• 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
• 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: 18026022
• Report Number: 3004478276-2023-00191
• Device Sequence Number: 7572505
• Product Code: LWR
• UDI-Device Identifier: 00896208000818
• UDI-Public: (01)00896208000818(240)PVF-L(17)261202
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 12/15/2023

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?: 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: 09/28/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2022
• 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: 89 YR
• Patient Sex: Male
• Patient Weight: 77 KG