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

Model Number TBD

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Abscess (1690); Fever (1858)

Event Type  Injury  

Event Description

The manufacturer received information on this event through the publication ''mycobacterium chimaera.A lethal enemy of cardiac surgery'' by ferrer et al.Based on the information reported on the paper, due to symptomatic severe aortic stenosis and significant disease of the left anterior descending (lad) coronary artery, a patient underwent aortic valve replacement with a perceval s bioprosthesis and left internal mammary artery to lad coronary bypass graft in july 2016.Ten days after surgery, a ddd pacemaker was implanted due to complete atrioventricular block.In december 2016, the patient was hospitalized for prolonged fever with shivering, headache and abdominal discomfort.A transthoracic (tte) and transesophageal (tee) echocardiogram showed a normally functioning aortic bioprosthesis without images of vegetations or periannular complications.In july 2017, the patient was re-hospitalized because of febrile syndrome and dissociated cholestasis.A tee showed an heterogenous image at the posterior annulus in continuity with anterior mitral valve leaflet, compatible with periaortic abscess.A new fdg pet/ct scan was performed and confirmed morphologic and metabolic progression with respect to the previous study, without evidence of pacemaker infection.Decision for surgical re-intervention was made.Aortic bioprosthesis and pacemaker were both removed and a new perceval valve and an epicardial electrocatheter were implanted.The paper reports that ultimately the patient passed away (not related to the perceval valve implanted).

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby V5J 5 M1; CA V5J 5M1
• MDR Report Key: 12280624
• MDR Text Key: 265160063
• Report Number: 1718850-2021-01144
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2021,08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TBD
• Device Catalogue Number: TBD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2021
• Date Manufacturer Received: 07/16/2021
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR