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

Model Number PB 10

Device Problems Fracture (1260); Occlusion Within Device (1423); Structural Problem (2506)

Patient Problems Death (1802); Endocarditis (1834); Pulmonary Regurgitation (2023); Stenosis (2263)

Event Date 03/23/2015

Event Type  Death  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.No unique device identifier (serial/lot) numbers were provided; without this information it cannot be determined whether this event has been previously reported.(b)(4).Citation: title: the clinical and hemodynamic outcomes up to 7 years after transcatheter pulmonary valve replacement in the us melody valve in vestigational device exemption trial.Authors: john p.Cheatham, md; william e.Hellenbrand, md; evan m.Zahn, md; thomas k.Jones, md; darren p.Berman, md; julie a.Vincent, md; doff b.Mcelhinney, md journal: circulation.2015;131:1960-1970.

Event Description

Medtronic received information via literature review that a study was performed to evaluate the clinical and hemodynamic outcomes up to 7 years after transcatheter pulmonary valve replacement in the us melody valve investigational device exemption trial.The study population included 171 patients (mean age of 19 years), 150 of which were implanted with medtronic melody transcatheter pulmonary valve (tpv) (serial numbers not provided).Among all patients, 4 deaths occurred, which included: 1 of multisystem failure resulting from sepsis/endocarditis and 3 of other causes with no apparent relationship to the melody valve (1 of respiratory failure and 2 of unknown causes).Among all patients, 32 adverse events occurred, which included: 32 patients underwent right ventricular outflow tract reintervention for obstruction (n=27, with stent fracture in 22), endocarditis (n=3, 2 with stenosis and 1 with pulmonary regurgitation), or right ventricular dysfunction (n=2).Eleven patients had the tpv explanted as an initial or second reintervention, pulmonary hypertension and increasing rv pressures was also noted in one patient.Five-year freedom from reintervention and explantation was 76±4% and 92±3%, respectively.A conduit pre-stent and lower discharge right ventricular outflow tract gradient were associated with longer freedom from reintervention.In the 113 patients who were alive and reintervention free, the follow-up gradient (median, 4.5 years after implantation) was unchanged from early post-tpv replacement, and all but 1 patient had mild or less pulmonary regurgitation.Almost all patients were in new york heart association class i or ii.More severely impaired baseline spirometry was associated with a lower likelihood of improvement in exercise function after tpv replacement.Conclusions¿tpv replacement with the melody valve provided good hemodynamic and clinical outcomes up to 7 years after implantation.Primary valve failure was rare.The main cause of tpv dysfunction was stenosis related to stent fracture, which was uncommon once prestenting became more widely adopted.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5322572
• MDR Text Key: 34240243
• Report Number: 2025587-2015-01374
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 11/25/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 00019 YR