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

Model Number PB1018

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Endocarditis (1834); Pulmonary Regurgitation (2023)

Event Date 03/30/2014

Event Type  Injury  

Event Description

Medtronic received information via a moderated poster contribution titled: "current results of the melody registry: an international multicenter registry of transcatheter pulmonary valve implantation" that between 12/2006 and 09/2013, 1,003 patients (mean age 21.5±11.4 years) underwent transcatheter pulmonary valve implantation (tpvi) in 40 cardiac centers.Indications for treatment were predominant stenosis, predominant regurgitation, or combined stenosis and regurgitation.The study retrospectively analyzed procedural details, clinical and echocardiographic outcome parameters.The primary outcome was freedom from death / reoperation / reintervention at one-year (all-cause and tpvi-related); for this analysis, 694 patients were included who reached one-year follow-up.Secondary outcomes included procedural complication rates, rates of endocarditis and stent fractures at one-year, as well as echocardiographic parameters of tpv device performance (peak right ventricular outflow tract (rvot) velocity and percentage of patients with significant pulmonary regurgitation (pr) of grade greater than 2).Results: the invasively measured right ventricular systolic pressure decreased significantly and so did the percentage of patients with significant pr of grade greater than 2.Procedural complications occurred in 2.7% (major) and 11.9% (minor) of tpvi procedures, respectively.The one-year freedom from the combined endpoint was 92.5% for all-cause events and 94.2% for tpvi-related events.At one-year, the rate of endocarditis was 2.7% and the rate of stent fractures was 11%.There was sustained hemodynamic performance of the tpvi device at one-year when compared to immediate post-intervention (peak rvot velocity: 2.5±0.7 versus 2.6±0.6 m/s; pr of grade greater than 2: 1% versus 2%).Conclusion: the multicenter melody registry represents the largest patient series after tpvi to date with a follow-up of one-year and offers the great potential for longer clinical observations of this patient population.The analysis of the current data confirms the safety and effectiveness of tpvi in clinical practice utilizing the melody valve.Adverse events noted in the study were: endocarditis, stent fracture, pulmonary regurgitation and 5.8 percentage of the patient's that did not meet the combined endpoint due to tpvi-related events (death / reoperation / reintervention), however the endpoints were not specifically broken out into separate endpoints.Citation: authors: johannes nordmeyer, peter ewert, marc gewillig, mario carminati, anselm uebing, lee benson, dietmar schranz, ingo daehnert, mansour aljufan, oliver kretschmar, felix berger, on behalf of the melody registry investigators, german heart institute berlin, berlin, germany title: "current results of the melody registry: an international multicenter registry of transcatheter pulmonary valve implantation" (a480, jacc april 1, 2014volume 63, issue 12).

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observations.The device and events noted in this report are from a poster presentation and device specific information is very limited.If further information becomes available, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

To date, serial numbers of individual devices have not been identified; without device serial numbers, a device history record review could not be conducted and it could not be determined whether these complaints had previously been reported, whether any of the complaints occurred before the device was commercially available, or if any of the complaint devices had been returned for analysis.Endocarditis, stent fracture, regurgitation and reoperation/re-intervention are known adverse events.However, without additional information or device analysis results, a root cause to these adverse events cannot be determined.(b)(4).

Manufacturer Narrative

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 east 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: 4197654
• MDR Text Key: 5151936
• Report Number: 2025587-2014-00787
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H080002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2014
• 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): Required Intervention
• Patient Age: 00021 YR