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

Model Number PVS23

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/28/2021

Event Type  Death  

Manufacturer Narrative

H3 other text : unknown disposition.

Event Description

The manufacturer was informed of a patient's death through the japan perceval heart valve study database.As reported in the database, a perceval s valve, size 23 was implanted on (b)(6) 2019 with median sternotomy surgical approach.The condition of the aortic valve was tricuspid, the aortic annulus was calcified, and the ascending aorta was normal.The operation was successful, and the patient was discharged on (b)(6) 2019; at discharge the patient was nyha ii, the cardiac rhythm was atrial fibrillation and the echocardiografic exam did not show any aortic regurgitation and reported a severe hypertrophy of the lvot.The patient underwent an laa ligation concomitant procedure as atrial fibrillation treatment on 10 december 2019.Reportedly, patient passed away on (b)(6) 2021 and the cause is unknown.Patient's clinical history included atrial fibrillation and was nyha class ii.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve and stent, model # icv1209, 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 # icv1209) perceval heart valve at the time of manufacture and release.Based on the limited information available, the definitive root cause of the event could not be established at this time since the cause of death is unknown.Furthermore, 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 SUTURELESS AORTIC HEART VALVE
• Type of Device: 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: 18914276
• MDR Text Key: 337787649
• Report Number: 3004478276-2024-00125
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)211128
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2021
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 78 KG