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

Model Number PB 10

Device Problem Perivalvular Leak (1457)

Patient Problems Endocarditis (1834); Unspecified Infection (1930); Sepsis (2067); Valvular Insufficiency/ Regurgitation (4449); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

Citation: breatnach cr et al.Procedural technique for hybrid pulmonary valve replacement in infants and small children.European journal of cardio-thoracic surgery.2021; 59:823-830.Doi: 10.1093/ejcts/ezaa410.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 a retrospective analysis into a hybrid technique of pulmonary valve replacement in a pediatric population.All data were collected from a single center between may 2017 and april 2019.The study population included 10 patients (predominantly female, median age 1.5 years, median weight 8.8 kg), all of whom were implanted with medtronic melody transcatheter pulmonary bioprosthetic valve (unique device identifier numbers not provided).Among all medtronic melody patients, adverse events included: sepsis leading to infective endocarditis (1 patient), wound infection (1 patient), severe pulmonary regurgitation (1 patient), and paravalvular leak (2 patients) requiring balloon angioplasty or a second valve.Based on the available information medtronic product was directly associated with the adverse events.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: 12277882
• MDR Text Key: 265146556
• Report Number: 2025587-2021-02454
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• 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: 07/16/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 18 MO
• Patient Weight: 9