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

Model Number PB 10

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pulmonary Valve Stenosis (2024); Cardiovascular Insufficiency (4445); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 11/09/2011

Event Type  Injury  

Manufacturer Narrative

Citation: hasan et al.Short-term performance of the transcatheter melody valve in high-pressure hemodynamic environments in the pulmonary and systemic circulations.Circ cardiovasc interv.2011 dec 1; 4(6):615-20.Doi: 10.1161/circinterventions.111.963389.Epub: (b)(6) 2011.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the immediate and short-term clinical results of the melody transcatheter pulmonary valve implanted in a high-pressure environment.All data were collected from multiple centers involved in the us ide (investigational device exemption) clinical trial of the melody valve.The study population included 29 patients (age and gender demographics not provided), all of whom were implanted with a medtronic melody valve (serial numbers not provided).Among all patients three deaths occurred.The authors stated the causes of death for all three patients were unrelated to the melody valve or implant procedure.Based on the available information medtronic product was not directly associated with the death(s).Among all patients adverse events included: four cases of moderate stenosis, 10% cases of mild regurgitation, and one transient occlusion of the left coronary artery.The transient occlusion of the left coronary artery occurred following implant and dilation of the melody valve due to native aortic valve leaflet entrapment in the left sinus.The patient became hypotensive, and cardiopulmonary resuscitation was initiated.Within five minutes of performing resuscitation the patient recovered when the melody valve moved approximately 1 mm toward the left ventricular apex which restored flow to the left coronary artery.Based on the available information medtronic product may have been associated with the adverse event(s).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: 10973063
• MDR Text Key: 220652733
• Report Number: 2025587-2020-03717
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• 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: 11/18/2020
• 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): Congenital Anomaly; Life Threatening; Required Intervention