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

Model Number	PB1018
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted, therefore no product analysis can be performed.Without return of the device, a conclusive cause cannot be determined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that approximately three years and three months following the implant of this transcatheter pulmonary bioprosthetic valve, a second transcatheter pulmonary bioprosthetic valve was implanted for an unknown reason.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
A dhr review was not required as the event description does not indicate a potential manufacturing issue.The event occurred three years post implant therefore it was unlikely that the event was due to device manufacturing.The event may have been due to patient outgrowth.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 was an unavoidable event; and eventually a reoperation and replacement of the conduit may be required.The device was not returned for analysis and no further information has been provided.Reason for intervention was not reported.Based on the limited received information, the failure mode cannot be determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MELODY TRANSCATHER 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: 7648394
• Report Number: 2025587-2018-01630
• Device Sequence Number: 152451
• Product Code: NPV
• UDI-Device Identifier: 00643169415874
• UDI-Public: 00643169415874
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P140017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

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: 07/21/2016
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 08/20/2018
• 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: 14 YR