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

Model Number PVS23

Device Problem Difficult to Open or Close (2921)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

The manufacturer was informed on this event through the publication: ''cusp thrombosis of a self-expandable sutureless aortic valve treated by valve-in-valve transcatheter aortic valve implantation procedure: case report'' by oezpeker et al.Based on the information reported on the paper, a patient presented for treatment of a highly symptomatic low-flow (svi: 23 ml/m2/1.73 m2 body surface area), low-gradient (mean: 38 mmhg) av stenosis (av area 0.52 cm2) with preserved ejection fraction (left-ventricular ejection fraction (lvef): 58%), and a very hypertrophic left ventricular myocardium.The patient underwent a minimally invasive aortic valve replacement, and a perceval valve size m was implanted in (b)(6) 2016.Both the intra- and post-operative course were uneventful.Discharge echocardiography showed a mean pressure gradient (mpg) across the av of 7 mmhg without av regurgitation.The patient was readmitted 10 months after ((b)(6) 2017) with symptoms of recurrent heart failure, dyspnoea, pulmonary congestion (oxygen saturation 94%), peripheral oedema, mild end-diastolic murmur, paced heart rate 78 b.P.M., nyha iv, and increased nt-probnp.Transthoracic echocardiography demonstrated recurrent av stenosis (av area 0.92 cm2), with a mpg of 12 mmhg with severe regurgitation and a preserved lv-ef.In (b)(6) 2017, transoesophageal echocardiography (toe) showed an immobile right-coronary cusp (rcc) due to bioprosthetic valve thrombosis (bvt).Cardiac computed tomography (ct) scan revealed a 12 x 4.9 mm thrombus at the ventricular aspect of the rcc and the right non-coronary commissure with an elliptic expansion shape (22.6 18.8 mm) of the bioprosthesis at the annulus level.Pharmacological therapy for thrombus resolution was initiated with systemic heparinization (aptt 50-60 s) followed by acenocoumarol (target inr: 2.5-3.5) for 3 months, according to the current guidelines/ recommendations.Because of further clinical deterioration and failure of thrombus resolution ((b)(6) 2017), the patient was considered for redo-savr or viv-tavi.Due to the high surgical risk, a transfemoral viv-tavi was performed under general anaesthesia using a 23 mm edwards-sapien 3 bioprosthesis in (b)(6) 2017.The procedure was completed uneventfully, and the patient had an uneventful post-operative course.The patient was discharged home on day 7 after tavi with the following anticoagulation regime: acenocoumarol (target inr 2-3) and 100 mg aspirin once per day.

• 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
• MDR Report Key: 12879706
• MDR Text Key: 286334404
• Report Number: 3019892983-2021-01041
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2021,11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2021
• Date Manufacturer Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female