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

Model Number PB10F18

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Pulmonary Valve Stenosis (2024)

Event Date 02/21/2017

Event Type  Injury  

Manufacturer Narrative

The device remains implanted; therefore, no product analysis can be performed. 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 nine years, six months and seven days following the implant of this 18mm transcatheter pulmonary bioprosthetic valve, a balloon angioplasty was performed on the stenotic melody valve. No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information was received which indicated that 70% systemic right ventricular (rv) hypertension from moderate stenosis at the level of the pulmonic valve had also developed. The condition resulted in a balloon aortic valvuloplasty (bav) nine years, six months and one day following the implant of the valve. An 18-millimeter (mm) x4 centimeter (cm) non-medtronic balloon was inflated to 12 standard atmosphere (atms). Trivial gradient (12 millimeters of mercury (mmhg)) was present post procedure. As reported, the bav was successful with good results. If information is provided in the future, a supplemental report will be issued.

• Brand Name: MELODY TRANSCATHER PULMONARY
• 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: 9226771
• MDR Text Key: 163765197
• Report Number: 2025587-2019-03249
• Device Sequence Number: 1
• Product Code: NPV
• 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,Followup,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/05/2008
• Device Model Number: PB10F18
• Device Catalogue Number: PB10F18
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 10/23/2019 Patient Sequence Number: 1