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

Model Number PB 10

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Endocarditis (1834); Pulmonary Valve Stenosis (2024)

Event Date 09/08/2020

Event Type  Injury  

Manufacturer Narrative

Citation: davtyan et al.Melody endocarditis does not equal valve removal: variations in practice in a multicenter experience.Pediatr cardiol.2020, 41:1248¿1298.Pics-aics 2020-pediatric and adult interventional cardiac symposium from 8 sep 2020 thru 11 sep 2020.Earliest date of conference 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 antibiotic therapy for endocarditis following implant of a melody bioprosthetic valve.All data were collected from four united states centers from 2010 to 2019.The study population included 666 patients (demographic information not provided), all of which were implanted with a medtronic melody bioprosthetic valve (unique device identifier numbers not provided).During a mean follow-up period of 2.9 years, 61 patients had endocarditis and 33 of those patients were treated medicinally with success.Two patients had recurrent endocarditis, one of which was treated medicinally and one which required surgery to explant the valve.Other valve explants were performed due to stenosis with or without right ventricular dysfunction, concern for inadequate response to antibiotics, and surgeon preference.Based on the available information medtronic product may have been associated with the adverse event(s).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: 12516579
• MDR Text Key: 272915393
• Report Number: 2025587-2021-02866
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• 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: 08/24/2021
• 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): Life Threatening; Required Intervention