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

Model Number PB 10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Valve Stenosis (2024); Regurgitation, Valvular (2335)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

Citation: tarzia, p.Et al percutaneous management of failed bioprosthetic pulmonary valves in patients with congenital heart defect s.Journal of cardiovascular medicine.2017; vol 18 no 6 doi 10.2459/jcm.0000000000000486.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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature review regarding percutaneous management of failed bioprosthetic pulmonary valves in patients with congenital heart defects.All data were collected retrospectively from a single center between 2008 and 2015.The study population included 6 patients, 4 of which were implanted valve-in-valve with medtronic melody transcatheter bioprosthetic pulmonary valve.It was reported that one patient had a previously implanted melody valve and one had a previously implanted freestyle valve.The study population was predominantly male; mean age 16 (10¿60) years, mean body weight 56 (31¿72) kg).Serial numbers not provided.Among all patients, no deaths occurred.Adverse events for the previously implanted melody and freestyle valves included; stenosis and equal to or less than moderate regurgitation treated with a valve-in-valve.Among all patients, implanted with a valve-in-valve, adverse events included: pulmonary regurgitation.No treatment was reported.Based on the available information, these events may have been attributed to medtronic product, however a direct correlation could not be made between the observed adverse events and medtronic product.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MELODY TRANSCATHER 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: 6853776
• MDR Text Key: 85570722
• Report Number: 2025587-2017-01563
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• 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: 08/21/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 16 YR
• Patient Weight: 56