MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHETER PULMONARY VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI

Model Number PB 10

Device Problem Thickening of Material (4056)

Patient Problems Pulmonary Embolism (1498); Aortic Valve Stenosis (1717); Endocarditis (1834)

Event Date 02/28/2021

Event Type  Injury  

Manufacturer Narrative

Citation: gierlinger et al.Surgical therapy of infective endocarditis following interventional or surgical pulmonary valve replacement.Eur j cardiothorac surg.2021 feb 28;ezab086.Doi: 10.1093/ejcts/ezab086.Online ahead of print.Earliest date of publish used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding surgical therapy of infective endocarditis following interventional or surgical pulmonary valve replacement.All data were collected from a single center between march 2013 and july 2020.The study population included 20 patients (predominantly male, mean age 15.9 years, mean weigh 53.6 kg) all with congenital heart disease and a diagnosis of infective endocarditis.Sixteen of the twenty patients were implanted with a medtronic melody valve (n = 11) or contegra bovine jugular vein graft conduit (n = 5).No unique device identifier numbers were provided.Among all patients, adverse events included: infective endocarditis, thickening of valve leaflets, stenosis, severe right ventricular dysfunction, and pulmonary artery embolism.Time to infective endocarditis of melody valve or contegra conduits ranged from 6 months to 9.4 years.Based on the available information medtronic product may have been associated with the adverse event(s).Treatment for all patients included reoperation to resect all infected prosthetic material from the right ventricular outflow tract up to the pulmonary bifurcation and replace with pulmonary homografts.Surgical findings of the infected conduits included: infection of valve leaflets only, massive valve or conduit destruction, and/or vegetation extended to other areas beyond the prosthetic.Post procedurally, six patients underwent additional procedures to address other issues.During follow-up, with a median of 205.5 days, there were no deaths and no cases of recurrent endocarditis.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MELODY TRANSCATHETER PULMONARY VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11918080
• MDR Text Key: 254220859
• Report Number: 2025587-2021-01746
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PB 10
• Device Catalogue Number: PB 10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2021
• 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): Congenital Anomaly; Life Threatening; Required Intervention
• Patient Age: 16 YR
• Patient Weight: 54