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

Model Number PB 10

Device Problems Gradient Increase (1270); Perivalvular Leak (1457); Device Dislodged or Dislocated (2923)

Patient Problems Mitral Regurgitation (1964); Thrombus (2101); Cardiac Perforation (2513)

Event Date 08/29/2017

Event Type  Injury  

Manufacturer Narrative

Citation: yoon, sh.Md.Et al.Transcatheter mitral valve replacement for degenerated bioprosthetic valves and failed annuloplasty ringsj.Joutnal of the american college of cardiology.(2017) vol.70, no.9 doi 10.1016/j.Jacc.2017.07.714 earliest date of e-publish/publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information, it cannot be determined whether this event has been previously reported.(b)(4).

Event Description

Medtronic received information via literature review regarding outcomes after a transcatheter mitral valve replacement (tmvr).All data were collected from a multi-center, multi-national registry between 2009 and 2017.The study population included 248 patients, all of which had a previously implant mitral annuloplasty ring, band or mitral bioprosthetic valve.Four patients were implanted valve-in-valve with a melody transcatheter bioprosthetic valve.Serial numbers were not provided.The study population was predominantly female; mean age 72.5 years.Among all patients adverse events included: conversion to surgery, left ventricular outflow tract (lvot) obstruction, valve dislodgement, the implant of a second valve, left ventricle perforation, thrombus, increased gradient measurements, and greater than moderate mitral regurgitation.Other adverse events included; reintervention due to paravalvular leak (pvl), atrial septal defect or surgical mitral replacement.Based on the available information, these events may have been attributed to a medtronic product.However as multiple manufacturers were noted in the literature, a direct correlation could not be made between the observed adverse events and the medtronic product.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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7133954
• MDR Text Key: 95373658
• Report Number: 2025587-2017-02505
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• 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: 11/22/2017
• 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): Required Intervention
• Patient Age: 72 YR