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

Model Number PVS23

Device Problem Calcified (1077)

Patient Problems Aortic Valve Stenosis (1717); Embolism/Embolus (4438)

Event Date 03/28/2023

Event Type  Injury  

Manufacturer Narrative

The manufacturer is following up with the site to retrieve further information regarding this event and the device involved.A follow up report will be provided upon receipt of any further information.H3 other text : sent by site to pathology department.

Event Description

The manufacturer was informed that on (b)(6) 2018 a patient was implanted with a perceval sutureless aortic heart valve pvs23 / size m.The patient's native valve was functionally bicuspid, with left and right coronary flap fusion without any further abnormalities.The patient's weight and height were 73 kg and 163 cm respectively at the time of operation.Medical therapy at the time of discharge was as follows: lansox; lasix; luvion; cardioaspirin; simvastatin; bisoprolol; relvar; coumadin (discontinued at three months).The valve was fully functional until an echocardiographic check performed on (b)(6)2022 revealed slightly increased gradients.From summer 2022, the patient experienced multiple cardioembolic events, with suspect of thrombus formation on the valve leaflets and severe aortic stenosis.The echographic and ct diagnostic exams performed confirmed increased gradients and prosthesis dysfunction.No change occurred after maximal anticoagulant therapy.As such, on (b)(6)2023 the patient was submitted to a redo surgery for aortic prosthesis replacement.Perceval valve was replaced with a surgical bioprosthesis from a different manufacturer (edwards lifesciences magna size 23).Upon explant, it was confirmed that the perceval valve presented calcified leaflets.The device was sent by the hospital to the pathological anatomy department of padova university for histological analysis which confirmed that valve stenosis was caused by severe calcific dystrophy.Reportedly, the operative course of the second surgery was smooth, but the patient had the need for definitive pm implantation due to complete av block.The patient was transferred to cardiological rehabilitation on day 14 and subsequently discharged home.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h6, h10.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 a manufacture¿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 is further following up with the site to retrieve additional information regarding this event and the device involved.A follow up report will be provided upon receipt of any further information.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h6, h10.The histological analysis performed by the pathological anatomy department of padova university confirmed that valve stenosis was caused by severe calcific dystrophy.The manufacturer received hard copies of echocardiographic evaluations performed on (b)(6) 2020, (b)(6) 2022, (b)(6) 2022, (b)(6) 2022 and of a ct scan performed on (b)(6) 2022.The analysis of the echocardiographic and ct images shared with the manufacturer allowed to confirm the correct sizing and positioning of the valve.No stent deformations which could have led to an abnormal behaviour of the prosthesis with consequent possible acceleration of the degenerative process were observed.This was also confirmed by the visual inspection performed on the returned valve.From the analysis of the ct scan acquired on (b)(6) 2022, a thrombus formation was clearly visible.Based on the review of the imaging exams available to the manufacturer and the analysis performed on the returned device, it is possible to exclude any valve mispositioning or abnormal behaviour as a possible contributing factor that could have accelerated the observed degenerative process.Furthermore, the review of manufacturing and material records of the perceval heart valve and stent 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, thus excluding any factor intrinsic to the device as a cause of the event.It has been reported that patient had multiple risk factors (i.E., hypertension, dyslipidemia, etc.).As such, patient condition could have played a major role in the premature degeneration of the prosthesis.

• 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 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: 16909859
• MDR Text Key: 314972764
• Report Number: 3004478276-2023-00143
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)220112
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2022
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2018
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 73 KG