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); Obstruction of Flow (2423); Migration (4003)

Patient Problems Stroke/CVA (1770); Exsanguination (1841); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Thrombus (2101); Low Cardiac Output (2501); Cardiac Perforation (2513); Vascular System (Circulation), Impaired (2572); Blood Loss (2597)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

Citation: yoon sh et al.Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification.Eur heart j.2019 feb 1;40(5):441-451.Doi: 10.1093/eurheartj/ehy590.Epub 2018 oct 23.Earliest date of publish used for event date.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.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the clinical outcomes of transcatheter mitral valve replacement for patients with degenerated bioprostheses, failed annuloplasty rings, and severe mitral annular calcification.All data were collected from 40 centers between february 2009 and april 2018.The overall study population included 521 patients (predominantly female; mean age 72 years), 4 of which were implanted valve-in-valve with medtronic melody transcatheter valves (melody valve implanted inside degenerated surgical bioprosthesis).No serial numbers were provided.Among all 322 patients in the valve-in-valve group, 20 deaths occurred within 30 days post implant.Multiple manufacturers were noted in the literature; based on the available information, medtronic product was not directly associated with the deaths.Among all 322 patients in the valve-in-valve group, adverse events included: conversion to surgery, need for second valve implantation, re-intervention (defined as paravalvular leak closure, atrial septal defect closure, alcohol septal ablation, or mitral valve replacement), left ventricle perforation, stroke, valve embolization, left ventricular outflow tract obstruction, mitral stenosis, clinical thrombosis, elevated mean gradients, moderate or higher mitral regurgitation, life-threatening/major or extensive bleeding, major vascular complications, and decreased left ventricular ejection fraction.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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8666623
• MDR Text Key: 146925302
• Report Number: 2025587-2019-01790
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H080002
• 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: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• 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: 05/09/2019
• 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