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

Model Number PB 10

Device Problems Partial Blockage (1065); Gradient Increase (1270)

Patient Problems Endocarditis (1834); Pulmonary Valve Stenosis (2024)

Event Date 01/24/2022

Event Type  Injury  

Manufacturer Narrative

Citation: samayoa j. , et al. Echocardiographic assessment of melody versus sapien valves following transcatheter pulmonary valve replacement. Jacc cardiovasc interv. 2022 jan 24;15(2):165-175. Doi: 10. 1016/j. Jcin. 2021. 11. 002. Pmid: 35057987 earliest date of publish used for date of event. Medtronic products referenced: melody (pma# p140017, product code: npv). Earliest approved product used for product code and pma#. No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported. Without return of the product no definitive conclusion can be made regarding the clinical observations. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the intermediate/mid-term performance of two competitor transcatheter pulmonary valves, based upon echocardiography. All data were retrospectively collected from a single center between 2011 and 2020. The study population included 328 pediatric and adult patients, with 202 of them implanted with medtronic melody bioprosthetic valves (predominantly male, mean age 14. 4 years, mean weight 49. 1 kg; unique device identifier numbers not provided). Among all medtronic melody patients, adverse events included: two cases of endocarditis with high transvalvular gradients and pulmonary stenosis (ps), requiring surgical explantation and pulmonary valve replacement. The timeline of endocarditis development was not reported within the article. Based on the available information medtronic product may have been associated with the adverse events. No further patient complications have been reported as a result of this event.

• Brand Name: MELODY TRANSCATHETER PULMONARY VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI
• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13832098
• MDR Text Key: 287585369
• Report Number: 2025587-2022-00745
• Device Sequence Number: 1
• Product Code: NPV
• 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: Literature,Health Professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: PB 10
• Device Catalogue Number: PB 10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• 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: 03/20/2022 Patient Sequence Number: 1