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

Model Number PB1018

Device Problems Fracture (1260); Gradient Increase (1270)

Patient Problems Pulmonary Valve Stenosis (2024); Right Ventricular Dysfunction (2054)

Event Date 02/01/2014

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device remains implanted, therefore no product analysis can be performed.   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 two years, six months, and thirteen days following the implant of this transcatheter bioprosthetic pulmonary valve into a stenotic 17 millimeter (mm) homograft, the valve was balloon dilated using a 22 millimeter (mm) non-medtronic balloon. The reason for dilation was not able to be confirmed, however it was suspected to be performed due to increased right ventricular (rv) pressure and increased rv-pulmonary artery (pa) pressures. Approximately nine years and fifteen days following the valve implant, the patient presented with moderate stenosis of the valve due to type ll (nordmeyer classification) stent fractures, right ventricular dilatation and dysfunction, a peak to peak gradient of approximately 50 mmhg, and right ventricular systolic pressures of 75 mmhg which is 2/3 of the systemic pressure. No treatment was performed. No additional 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: 10460600
• MDR Text Key: 204574115
• Report Number: 2025587-2020-02688
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/07/2013
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/07/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/27/2020 Patient Sequence Number: 1