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

Model Number PB1018

Device Problem Gradient Increase (1270)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Cardiac Output (2501); Cardiovascular Insufficiency (4445); Valvular Insufficiency/ Regurgitation (4449); Pulmonary Valve Insufficiency/ Regurgitation (4452); Swelling/ Edema (4577)

Event Date 02/28/2022

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device remains implanted, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that approximately eight years and four months following implant of this transcatheter bioprosthetic pulmonary valve into a patient with a previously implanted homograft (manufacturer unknown) for tetralogy of fallot (tof), the patient reported leg edema, moderate reduced left ventricle function, right ventricle (rv) dilation and reduced systolic function.It was reported that the valve had trivial insufficiency.Approximately a month and a half later, a diagnostic catheterization was performed again revealing post-capillary pulmonary hypertension , rv to pulmonary artery (pa) gradient of 45mmhg with nearly systemic rv pressure, confirmation of reduced left ventricle function, and no relevant atrial shunt.The rv pressure measured 90 mmhg, the pa pressure measured 58 mmhg and the femoral artery pressure measured 100 mmhg.Approximately eight years and seven months following the initial implant of this valve, the valve was re-dilated using a 24 mm non-medtronic balloon.The valve was then replaced with a second transcatheter bioprosthetic pulmonary valve.The replacement valve was post-dilated using a 24 mm non-medtronic balloon.The rv to pa pressure following the replacement valve was 8 mmhg.No additional adverse patient effects 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13636651
• MDR Text Key: 286362223
• Report Number: 2025587-2022-00555
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2022

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: Health Professional
• Device Expiration Date: 05/21/2015
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/01/2022
• Date Device Manufactured: 06/05/2013
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 120 KG