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

Model Number PB1016

Device Problem Gradient Increase (1270)

Patient Problems Calcium Deposits/Calcification (1758); Right Ventricular Dysfunction (2054)

Event Date 08/05/2019

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 one year and 12 days following the implant of this transcatheter pulmonary bioprosthetic valve, the valve was removed and replaced with a conduit.The reason for explant and replacement was increased exercise intolerance, increased right ventricular outflow tract (rvot) gradient to 40 mmhg, right ventricle systolic pressure at 76%, and significant calcification.No additional adverse patient effects were reported.

• Brand Name: MELODY TRANSCATHETER 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: 9124684
• MDR Text Key: 160207663
• Report Number: 2025587-2019-02928
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00643169588189
• UDI-Public: 00643169588189
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2019
• Device Model Number: PB1016
• Device Catalogue Number: PB1016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2019
• Date Device Manufactured: 04/04/2017
• 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: 14 YR
• Patient Weight: 65