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

Model Number	PB1016
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pulmonary Valve Stenosis (2024); No Information (3190)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: no product was returned.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 or Problem Description
Medtronic received information that approximately five years, five months and sixteen days following the implant of this transcatheter pulmonary bioprosthetic valve, the valve was surgically explanted and replaced with a medtronic surgical valve.The reason for explant and replacement was not reported.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Additional information was received that the valve was explanted due to stenosis.No additional adverse patient effects were reported.  product analysis: the device was discarded, therefore no product analysis can be performed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MELODY TRANSCATHETER PULMONARY VALVE
• Common Device Name: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10579901
• Report Number: 2025587-2020-02917
• Device Sequence Number: 3209136
• Product Code: NPV
• UDI-Device Identifier: 00643169415850
• UDI-Public: 00643169415850
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P140017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2016
• Device Model Number: PB1016
• Device Catalogue Number: PB1016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR
• Patient Weight: 55