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

Model Number PB 10

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Ventricular Fibrillation (2130); Cardiogenic Shock (2262); Heart Block (4444); Respiratory Insufficiency (4462)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

Citation: megaly m et al.Outcomes of percutaneous and surgical pulmonary valve implantation.Cardiovasc revasc med.2021 jan 4;s155 3-8389(20)30842-3.Doi: 10.1016/j.Carrev.2020.12.035.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 in-hospital outcomes with percutaneous pulmonic valve implantation (ppvi) and surgical pulmonic valve implantation (spvr) in adult hospitals in the united states after approval and commercial availability of the melody and sapien xt valves.The authors searched the national inpatient sample database and obtained information for ppvi and spvr hospitalizations from january 2016 to december 2017.The study population included 5,445 patients (ppvi=1140, spvr=4305).In the ppvi group, the demographic data was as follows: predominantly male, median age 21 years, and 52.6% white.An un disclosed number of patients underwent ppvi with medtronic melody transcatheter pulmonary valves.No unique device identifier numbers were provided.Among all ppvi patients, 10 in-hospital deaths occurred.None of the deaths were directly associated with medtronic product.Among all ppvi patients, in-hospital adverse events included: conversion to spvr, stroke (ischemic or hemorrhagic), cardiac arrest, cardiogenic shock, complete heart block, permanent pacemaker implantation, ventricular arrhythmias, st elevation myocardial infarction, intra-aortic balloon pump support, vascular complications requiring surgery, percutaneous coronary intervention, bleeding, blood transfusion, and respiratory complications.Based on the available information, medtronic product may have been 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 DELIVERED
• 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: 11373446
• MDR Text Key: 234623289
• Report Number: 2025587-2021-00663
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/24/2021
• 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
• Patient Age: 21 YR