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

Model Number PB1018

Device Problem Occlusion Within Device (1423)

Patient Problems Pulmonary Insufficiency (2022); Thrombus (2101); Stenosis (2263)

Event Date 11/17/2014

Event Type  Injury  

Manufacturer Narrative

A review of the device history record could not be performed without the serial number.Thrombus, stenosis and regurgitation are known adverse events for this device.

Manufacturer Narrative

It was reported that the device will be returned for analysis.A supplemental report will be filed when the analysis/investigation is completed.(b)(4).

Event Description

Medtronic received information that stenosis and valvular insufficiency were observed three years post- implant of this transcatheter pulmonary valve (tpv).Subsequently, the patient underwent surgical explant of the valve with another manufacturer¿s device implanted in preparation for a liver transplant.The explanted valve was sent to pathology at the hospital, which revealed an organized thrombus or mass on the valve.No subsequent adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4318583
• MDR Text Key: 12900646
• Report Number: 2025587-2014-01007
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H080002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: No
• 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