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

Model Number PB 10

Device Problem Gradient Increase (1270)

Patient Problems Endocarditis (1834); Pulmonary Valve Stenosis (2024); Pulmonary Valve Insufficiency/ Regurgitation (4452); Unspecified Heart Problem (4454)

Event Date 12/11/2021

Event Type  Injury  

Manufacturer Narrative

Citation: davtyan a, et al. Selective valve removal for melody valve endocarditis: practice variations in a multicenter experience. Pediatr cardiol. 2021 dec 11. Doi: 10. 1007/s00246-021-02801-z. 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 from a literature article regarding the factors associated with surgical explantation versus antimicrobial therapy in patients with melody valve endocarditis. All data was retrospectively collected from four centers between october 2010 and march 2019. A total of 663 medtronic melody transcatheter pulmonary valves were implanted during the study period. Of these, 59 patients developed endocarditis and were included in the study population (predominantly male, median age 19. 5 years). Some patients had recurrence (second or third episode of endocarditis), resulting in a total of 66 cases of endocarditis. Of the 59 patients in the study population, four deaths occurred during endocarditis treatment. Causative organisms included: culture (b)(6): (b)(6), and cardiobacterium hominis. Time from melody valve implant to onset of endocarditis ranged between 2. 1 and 7. 5 years. Based on the time from melody valve implant to endocarditis, none of these deaths were related to the valve. One additional death occurred due to end-stage renal disease more than 1. 4 years after successful treatment of endocarditis and was stated to be unrelated to the melody valve. Of the 66 cases of endocarditis, 39 were treated with intravenous antimicrobials and 27 cases had the melody valve surgically explanted with concurrent antimicrobial therapy. Other interventions reported: transcatheter balloon valvuloplasty, and transcatheter valve-in-valve replacement after completing treatment for endocarditis. Median time from melody valve implant to onset of endocarditis was 2. 3 years (range, 1. 2 to 4. 6) for the valve not explanted group and 2. 8 years (range, 1. 7 to 5. 1) for the valve explanted group. Causative organisms included: streptococcal species, (b)(6), culture (b)(6)/unknown, hacek organisms, enterococcus species, bartonella henselae, other bacteria, and fungus. Reasons for melody valve explant included: stenosis, right ventricular dysfunction, severe regurgitation/insufficiency, vegetations, surgeon preference, concern for inadequate response to antimicrobials, and recurrent endocarditis. Increased right ventricular outflow tract gradients were also observed. Additionally, the authors reported that five of the 59 patients in the study population had a medtronic contegra valved conduit in place prior to melody valve implant, indicating these patients had undergone transcatheter valve-in-valve replacement (melody valve implanted inside contegra conduit). The reasons for replacement were not provided. No unique device identifier numbers were provided. 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: 13500524
• MDR Text Key: 289355467
• Report Number: 2025587-2022-00399
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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: 01/11/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/09/2022 Patient Sequence Number: 1