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

Model Number PB1018

Device Problem Gradient Increase (1270)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758); Pulmonary Valve Stenosis (2024)

Event Date 05/12/2017

Event Type  Injury  

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the valve inflow struts were flared out and a piece of pannus was found attached on the outside of the inflow struts.Calcification was noted on the pannus, found attached on the outside of the inflow struts.Radiography confirmed extensive calcification on the attached pannus.Pannus was also observed on the top of the inflow and the outflow crown.The leaflets were thickened, but were flexible and intact.The leaflets were open against the inner lumen and no visible pannus or calcification was noted on the leaflets.The commissures of the valve were found to be intact.Radiography could not confirm calcification on the valve.Conclusion: calcification and pannus have been an inherent risk of cardiac surgeries.Due to the fact that a great proportion of congenital heart valve abnormalities present as emergent cases in neonates, infants and young children, the patient¿s physical growth is an unavoidable event; and eventually a reoperation and replacement of the device may be required.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.

Event Description

Medtronic received information that three years following the implant of this transcatheter pulmonary bioprosthetic valve (tpbv), echocardiogram showed a gradient of 40 mmhg across the valve.The valve was removed due to stenosis and surgically replaced with a bioprosthetic valve.During the valve replacement procedure, severe calcification was identified in the right ventricular outflow tract.Per the physician, the valve was severely stenotic secondary to dysplastic and fibrotic leaflets within the valve.The physician noted that an element of outgrowth was a factor in the performance of the valve, but stated that the leaflet degeneration was the primary cause of the stenosis of the valve.No other adverse patient effects were reported.

• Brand Name: MELODY TRANSCATHER PULMONARY
• 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: 6830812
• MDR Text Key: 83984774
• Report Number: 2025587-2017-01502
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00613994663962
• UDI-Public: 00613994663962
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2015
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2013
• 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): Required Intervention
• Patient Age: 14 YR
• Patient Weight: 56