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)

Patient Problem Pulmonary Valve Stenosis (2024)

Event Date 05/27/2014

Event Type  Injury  

Manufacturer Narrative

Citation: meadows et al.Use and performance of the melody transcatheter pulmonary valve in native and postsurgical, nonconduit right ventricular outflow tracts.Circ cardiovasc interv.2014;7:374-380.Doi: 10.1161/circinterventions.114.001225.Earliest date of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.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.

Event Description

Medtronic received information via literature regarding the use and performance of melody transcatheter pulmonary valve when implanted in a non-conduit right ventricular outflow tract (rvot).All data were collected retrospectively from multiple centers.The study population included 31 patients (50% male <(>&<)> 50% female; median age 24 years; median weight 62 kg), all of which were implanted with medtronic melody transcatheter pulmonary valve (serial numbers not provided).Among all patients, adverse events included: 30 pulmonary regurgitation (none to trivial = 19, mild = 11), 3 endocarditis or blood stream infections (2 identified as vegetations on the melody valve, all successfully treated with antibiotics), and 1 rvot tear during initial balloon angioplasty that may have occurred with melody implanted (successfully treated with placement of a covered stent).Among all patients, device malfunctions included: 8 moderate or greater valve obstruction associated with stent fracture.Three patients underwent repeat melody valve placement because of stent fracture and recurrent obstruction.There were two melody valve explantations, both of whom had undergone a second melody valve implantation.The first patient developed multiple stent fractures and underwent repeat melody valve implantation at 14 months post-implant.Although the second valve demonstrated minimal obstruction and no insufficiency, both valves were explanted during a subsequent surgical repair of a complex coarctation of the aorta.One additional patient developed stent fracture and reobstruction at 5 months post-implant.This patient was brought back to the cardiac catheterization laboratory where additional bare metal stents were placed, followed by an additional melody valve.Subsequently, the patient developed ventricular tachycardia likely related to the stent position.Several days later all stents were explanted.No further details were provided on these cases.No additional adverse patient effects or product performance issues were reported.

• 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 HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6854058
• MDR Text Key: 85573066
• Report Number: 2025587-2017-01567
• 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
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• 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: 08/10/2017
• 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): Life Threatening; Required Intervention
• Patient Age: 24 YR
• Patient Weight: 62