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

Model Number PB1018

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Valve Stenosis (2024)

Event Date 10/24/2017

Event Type  Injury  

Manufacturer Narrative

Product analysis: the valve has not been returned for analysis, however.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that approximately one year and nine months following the implant of this transcatheter pulmonary bio prosthetic valve (tpbv), stenosis with subsequent dysfunction was observed.Subsequently, a second tpbv was implanted valve-in-valve.No adverse patient effects were reported.

• Brand Name: MELODY TRANSCATHER 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: 7050393
• MDR Text Key: 92674401
• Report Number: 2025587-2017-02243
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00643169588196
• UDI-Public: 00643169588196
• 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: 11/21/2017

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: 06/22/2017
• 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: 11/01/2017
• Initial Date FDA Received: 11/21/2017
• Date Device Manufactured: 10/16/2015
• 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: 9 YR
• Patient Weight: 27