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

Model Number PB 10

Device Problems Partial Blockage (1065); Gradient Increase (1270)

Patient Problem Pulmonary Valve Stenosis (2024)

Event Date 06/05/2020

Event Type  Injury  

Manufacturer Narrative

Citation: takajo d., et al.Recurrent infective endocarditis in a patient after a second melody valve placement.Cardiol young.2020 jun 5:1-2.Pmid: 32498746.Doi: 10.1017/s1047951120001389.[published online by cambridge university press: 05 june 2020] 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 a (b)(6)-year-old caucasian male patient with congenital pulmonary valve atresia with ventricular septal defect that was surgically repaired in infancy.At age 10 years, the pulmonary conduit demonstrated stenosis with pulmonary regurgitation.The patient underwent dilatation/stenting of the pulmonary conduit along with implantation of an 18-mm medtronic melody bioprosthetic valve (no serial number provided).At age 14 years, the patient was hospitalized and underwent re-dilatation of the conduit and valve due to severe re-stenosis and high transvalvular gradients.This procedure was repeated twice more, 8 and 11 months later, for refractory worsening stenosis with unacceptable pressure gradients.As this issue remained unresolved, a second melody valve was implanted within the first melody valve (no serial number was provided).Four months after implantation, the patient was hospitalized and the pulmonary conduit was noted, by echocardiography, to have developed moderate stenosis with increased transvalvular gradients.It was noted the patient was awaiting surgery to replace the conduit to resolve the condition.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: 10208518
• MDR Text Key: 201174246
• Report Number: 2025587-2020-02063
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PB 10
• Device Catalogue Number: PB 10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2020
• Initial Date FDA Received: 06/29/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 16 YR