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

Model Number PB 10

Device Problems Gradient Increase (1270); Material Separation (1562); Obstruction of Flow (2423)

Patient Problems Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024); Heart Failure (2206)

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 2: a (b)(6)-year-old male patient with a history of truncus arteriosus and two reoperations for replacement of the right ventricle to pulmonary artery conduit.At age 29, he had a 22 mm medtronic melody transcatheter pulmonary valve (serial number not provided) implanted in the existing right ventricle to pulmonary artery homograft due to regurgitation and stenosis.Three years later, the patient presented with acute right heart failure with pedal edema, hepatomegaly, and limited exercise capacity.A transthoracic echocardiogram showed severe stenosis of the melody valve with an elevated peak gradient (80 mmhg).A cardiac catheterization with intracardiac echocardiogram was performed and revealed loss of contact between the valve and the valve stent which produced a ¿hammocking¿ movement causing severe regurgitation and stenosis.Subsequently, a second 22 mm melody valve (serial number not provided) was implanted valve-in-valve.Two years later, it was reported that the second melody valve showed good function with mild residual stenosis.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: 9507860
• MDR Text Key: 187044606
• Report Number: 2025587-2019-03863
• 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: 32 YR