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

Model Number PB 10

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Endocarditis (1834); Hemorrhage/Bleeding (1888); Pulmonary Valve Stenosis (2024)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

Citation: bensemlali et al.Percutaneous pulmonary melody valve implantation in small conduits: early and long-term results.Cardiology in the young: volume 26, supplement 1, pages s1¿s181.50th annual meeting of the association for european paediatric and congenital cardiology (aepc).Rome, italy.June 1-4, 2016.Doi:10.1017/s1047951116000500.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 via literature regarding early and long-term results for melody valve implantation in pulmonary small conduits.All data were collected from multiple centers between 2009 and 2015.The study population included 11 patients (gender, age, weight demographic data not provided), all of which were implanted with a medtronic melody bioprosthetic valve (unique device identifier numbers not provided).There were four early complications: two confined conduit tears managed with placement of a covered stent, and two local vascular complications requiring prolonged hospital stay.With a mean follow-up period of 3.6 years, there were four late complications: two endocarditis requiring surgical removal, and two recurrent stenosis with one requiring surgical conduit replacement and one a percutaneous melody re-dilatation.Based on the available information medtronic product was directly 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 DELI
• 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: 12418489
• MDR Text Key: 269767269
• Report Number: 2025587-2021-02737
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• 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: 08/24/2021
• 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): Hospitalization; Life Threatening; Required Intervention