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

Model Number PB1018

Device Problems Gradient Increase (1270); Obstruction of Flow (2423); Insufficient Information (3190)

Patient Problems Pulmonary Valve Stenosis (2024); No Consequences Or Impact To Patient (2199)

Event Date 01/13/2020

Event Type  Injury  

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 Description

Medtronic received information that approximately nine years following the implant of this transcatheter pulmonary bioprosthetic valve, a second transcatheter pulmonary valve was implanted for an unknown reason.No additional adverse patient effects were reported.

Manufacturer Narrative

Additional information was reported that stenosis was present with a gradient of more than 35 millimeter (mm) of mercury (hg).A balloon aortic valvuloplasty (bav) was performed but could not relieve the high gradient of the first valve.A stent was placed and the second valve was implanted valve-in-valve.The previously reported aware date/date received by manufacturer of january 13, 2020 is no longer valid.Aware date/date received by manufacturer of the event was corrected to (b)(6), 2020.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 9681834
• MDR Text Key: 178153114
• Report Number: 2025587-2020-00406
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00613994663962
• UDI-Public: 00613994663962
• Combination Product (y/n): N
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2012
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 89