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

Model Number PVS23

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Embolism/Embolus (4438)

Event Date 06/13/2022

Event Type  Death  

Event Description

A patient underwent an aortic valve replacement with a perceval m valve on (b)(6) 2022 due to aortic valve stenosis.A concomitant cabg x3 was performed, left atrial appendage occlusion, and partial ablation of the left atrium for atrial fibrillation.The procedure was completed uneventfully, and the patient was transferred to the icu in hemodynamically stable conditions.The patient had signs and symptoms of stroke post-surgery ((b)(6) 2022).Ct head nad.Was planned for follow up mri.The patient had some thickened fluids.The patient apparently had a distended abdo.A ct abdo was planned.On way to ct, the patient vomited, aspirated, arrested, and couldn¿t be revived.The patient unfortunately died on (b)(6) 2022.The patient was therapeutically warfarinised at time of stroke.Background history includes obesity, hypertension, type ii diabetes mellitus, increased cholesterol, atrial fibrillation.Other medical history includes prostate cancer and lung cancer.

Manufacturer Narrative

Unknown device disposition.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, 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 satisfied all material, visual, and performance standards required for a (model #icv1209) perceval heart valve at the time of manufacture and release.The manufacturer attempted to retrieve additional information on this event.However, no further information has been provided to date, despite the manufacturer's attempts.Based on the information available, it is not possible to establish a definitive root cause of the reported event.However, from the document review performed, no manufacturing deficiencies were identified.It is possible that patient clinical, history and risk factors (i.E.Obesity, hypertension, increased cholesterol, atrial fibrillation) has contributed to the reported event but since the device was not returned to the manufacturer for further investigation, this cannot be ultimately confirmed.Should any further information be received in the future, the manufacturer will submit a follow up report.

• 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: roberta lamberti ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 14981812
• MDR Text Key: 295671598
• Report Number: 3004478276-2022-00167
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)240929
• 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: 08/09/2022

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
• Device Operator: Health Professional
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 07/11/2022
• Supplement Dates Manufacturer Received: 07/14/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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): Other; Death
• Patient Age: 73 YR
• Patient Sex: Male