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

Model Number PB 10

Device Problems Obstruction of Flow (2423); Incomplete Coaptation (2507)

Patient Problems Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024); Right Ventricular Hypertrophy (2056)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

Citation: jhaveri s et al.Hammock effect and complete cusp prolapse: rare mechanisms of melody valve failure demonstrated by intracardiac echocardiography.Ann pediatr cardiol.2019 sep-dec; 12(3): 342¿344.Doi: 10.4103/apc.Apc_143_18.Earliest date of publish used for event date (month and year valid).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 two case reports in which intracardiac echocardiography identified unique complications associated with the melody valve.Patient 1: a (b)(6)-year-old male patient with a history of truncus arteriosus and truncal valve repair using a right ventricle to pulmonary artery homograft conduit.At age (b)(6), the patient had a 20 mm medtronic melody transcatheter pulmonary valve (serial number not provided) implanted in the existing homograft conduit due to severe conduit regurgitation with right ventricular dilation.After melody implant, mild residual stenosis was noted.Six years later, a transthoracic echocardiogram and cardiac magnetic resonance imaging showed severe pulmonary regurgitation with right ventricle dilation.An elective cardiac catheterization was performed.During the procedure, an intracardiac echocardiogram revealed complete prolapse of the melody valve leaflets without any coaptation causing severe regurgitation.Subsequently, a second melody valve (22 mm; serial number not provided) was implanted valve-in-valve.One-year later, it was reported that the function of the second melody valve was excellent.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: 9507828
• MDR Text Key: 172562299
• Report Number: 2025587-2019-03862
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• 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: 12/03/2019
• 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: 19 YR