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

Model Number PB1018

Device Problem Fracture (1260)

Patient Problem Pulmonary Valve Stenosis (2024)

Event Date 09/20/2011

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 four years, nine months and six days following the implant of this transcatheter pulmonary bioprosthetic valve without pre-stenting, patient outgrowth of the device revealed stenosis. Intervention was required for the stenosis. A dilation was occurred with a high-pressure balloon. The dilation revealed a stent fracture of the valve and required the implant of a stent and a second transcatheter pulmonary bioprosthetic valve. 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: 9565159
• MDR Text Key: 174172598
• Report Number: 2025587-2020-00082
• 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
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/28/2007
• 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: 01/13/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/28/2006
• 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: 01/08/2020 Patient Sequence Number: 1