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

Model Number PB 10

Device Problems Burst Container or Vessel (1074); Fracture (1260); Obstruction of Flow (2423); Migration (4003)

Patient Problems Endocarditis (1834); Pulmonary Valve Stenosis (2024); Vascular System (Circulation), Impaired (2572)

Event Date 08/18/2015

Event Type  Injury  

Manufacturer Narrative

Citation: virk sa et al.Percutaneous pulmonary valve implantation: a systematic review of clinical outcomes.Int j cardiol.2015 dec 15;201:487-9.Doi: 10.1016/j.Ijcard.2015.08.119.Epub 2015 aug 18.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 the 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 an assessment of the clinical outcomes in patients with right ventricular outflow tract (rvot) dysfunction who underwent percutaneous pulmonary valve implantation (ppvi).All data were collected from a meta-analysis systematic review of twelve studies between 2008 and 2014.The study population included 677 patients and was predominantly male with a mean age of 21 years.Of those, 602 were implanted with medtronic melody transcatheter pulmonary valves.No serial numbers were provided.Among all patients, 5 deaths were reported.Of those, an unidentified number may have been due to endocarditis (earliest case occurred at 1.9 months after ppvi).Based on the available information, medtronic product may have been associated with the deaths.Among all patients, adverse events included: conversion to surgery; conduit rupture; endocarditis (earliest case occurred at 1.9 months after ppvi); valve explant due to endocarditis; valve embolization; pulmonary artery obstruction; coronary artery compression; and restenosis and rvot reintervention due to stent fractures.Based on the available information, medtronic product was associated with the adverse events.Among all patients, malfunctions included: stent fractures that did not require intervention.Based on the available information, medtronic product was associated with the malfunctions.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: 9900346
• MDR Text Key: 196438567
• Report Number: 2025587-2020-01010
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• 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: 03/25/2020
• 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: 21 YR