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

Model Number PVF-M

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Heart Block (4444)

Event Date 09/20/2022

Event Type  Injury  

Manufacturer Narrative

Still implanted.

Event Description

The manufacturer was informed of the following event through mantra study.Based on the information provided, pvf-m was implanted on (b)(6) 2022 through median sternotomy.The concomitant procedure was cabg.On (b)(6) 2022 conduction disturbance (av block iii) was started which led to pacemaker implantation.Based on the information available, patient had a history of coronary artery disease, arrhythmia (atrial fibrillation), systemic hypertension, diabetes mellitus type ii, dyslipidemia, malignancy which was resolved, hypothyroid, depression, hysterectomy with anexectomy, and nyha class ii.Furthermore, patient was taking warfarin.Based on the site assessment the event was not device related and was probably related to the procedure and patient's primary condition being treated.

Manufacturer Narrative

The manufacturing and material records for the perceval plus heart valve and stent, 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 satisfied all material, visual, and performance standards required for a (model #pvf-m) perceval plus heart valve at the time of manufacture and release.Based on the document review performed, no manufacturing deficiencies were identified.Conduction disorders are common in patients with aortic valve diseases.As a result, it is common for patients to receive permanent pacemaker implantation after aortic valve replacement.Risk factors include preexisting conducting disease (i.E., arrhythmia (atrial fibrillation), and preoperative aortic regurgitation.Based on the medical assessment received from the site, the event was not device related and was probably related to the procedure and patient's primary condition being treated.Should further information be received in the future, a follow up report will be provided.

• Brand Name: PERCEVAL PLUS 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: 15900436
• MDR Text Key: 304681964
• Report Number: 3004478276-2022-00211
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000801
• UDI-Public: (01)00896208000801(240)PVF-M(17)260325
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011/S013
• 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: 01/03/2023

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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 11/05/2022
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 67 KG