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

Model Number PB 10

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Endocarditis (1834); Unspecified Infection (1930); Pulmonary Valve Stenosis (2024)

Event Date 11/19/2021

Event Type  Injury  

Event Description

Medtronic received information via literature regarding a (b)(6) male patient with a complicated medical history of shone¿s complex, multiple interventions including aortic valvuloplasty and coarctation stenting, and a finally a ross procedure at the age of (b)(6). Over time the patient developed progressive pulmonary conduit stenosis and in (b)(6) 2020 underwent implant of a medtronic 22-mm melody bioprosthetic valve (unique device identifier numbers not provided) in the pulmonary position. Approximately three months later, the patient presented with profound respiratory distress and clinical symptoms of sepsis requiring inotropic and ventilatory support. A transthoracic echocardiogram (tte) confirmed severe stenosis of the implanted pulmonary valve, worsening rv dilation and severe rv dysfunction. Antibiotic therapy led to an improvement in inflammatory markers and clearance of blood cultures prior to intervention. Intracardiac echocardiography (ice) demonstrated significant pulmonary valve dysfunction with a gradient of 54 mmhg and evidence of endocarditis as extensive mobile vegetations along the length of the conduit and the implanted pulmonary valve. Due to the patient¿s decompensated state, the heart team elected to perform a transcatheter implant of a non-medtronic sapien s3 valve within a covered stent deployed simultaneously to exclude the mass of infected tissue within the right ventricular outflow tract (rvot) and improve hemodynamics. Post-procedural hemodynamics showed an overall gradient of 10 mmhg across the rvot, and good function of the pulmonary valve with no regurgitation and no obstruction. The patient was discharged 12 days after this procedure in stable condition. After a 6-week course of antibiotic therapy the patient¿s cultures were clear, and rv function and overall health had improved. Two months after this urgent intervention, the patient then underwent a surgical explantation of the ¿homograft/stent/melody/stent/sapien s3 complex¿ and successful placement of a non-medtronic 29-mm trifecta transcatheter valve. Examination of the explanted devices showed no evidence of abscess formation or gross vegetations nor any thickening or degeneration of valve leaflets. Each component of the explanted complex was separated and sent for bacterial culture assessment. No micro-organism was identified; however, multiple bacterial cocci were present. The patient was discharged home on post-operative day five. At follow-up three months later, the patient had completed antibiotic regimen and remained fever- and symptom-free. No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: shorofsky et al. Simultaneous deployment of a covered stent and a sapien s3 as a bridge to surgical valve replacement in acute infective endocarditis. Journal of cardiology cases, 2021. E-published november 19, 2021. Https://doi. Org/10. 1016/j. Jccase. 2021. 10. 007. Earliest date of publish used for date of event. 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.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13519223
• MDR Text Key: 289602434
• Report Number: 2025587-2022-00435
• 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: 02/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2022
• 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: 01/14/2022
• 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: 02/12/2022 Patient Sequence Number: 1