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); Migration or Expulsion of Device (1395); Perivalvular Leak (1457)

Patient Problems Ventricular Tachycardia (2132); Regurgitation, Valvular (2335); Vascular System (Circulation), Impaired (2572)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

Citation: hill k et al.Post-market surveillance to detect adverse events associated with melody® valve implantation.Cardiology in the young 2016; pages 1-8.Doi:10.1017/s1047951116002092.Earliest date of publish used for event date.(b)(4).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 adverse events associated with the medtronic melody bioprosthetic valve (serial numbers not provided).All data were collected from the food and drug administration manufacturer and user facility device experience (maude) database from january 2010 to july 2015 as well as literature searches from embase and medline databases.The study population mean gender, age or weight were not provided, however, the review included a total of 631 adverse events with on-label use and 84 adverse events with off-label use.Among all the patients an unspecified number of deaths occurred.Causes of death in four patients included: coronary compression, right pulmonary artery obstruction, and ventricular arrhythmia.None of the deaths were attributed to medtronic product.Procedure-related adverse events included: conduit rupture/tear, access site complication, guidewire perforation, hemodynamic changes, coronary compression, ventricular tachycardia, paravalvular leak, device embolization, device malposition, insufficiency, stenosis, complete heart block, pulmonary artery obstruction, aorto-pulmonary fistula formation, and accidental unsheathing.Several of these events required intervention.Device-related adverse events included: stent fracture, device embolization, aorto-pulmonary fistula formation, coronary compression, and endocarditis.The endocarditis infectious organisms were noted as: staphylococcus aureus, viridans streptococci, coagulase-negative staphylococcus, and hacek (haemophillus, aggregatibacter, actinobacillus, cardiobacter, eikenella, kingella).Additionally, cases of off-label use (defined by implant position or use in patients under 30kg) were assessed.Off-label adverse events included: tricuspid and mitral regurgitation, device embolization, conduit tear, vascular complication, aorto-pulmonary fistula formation, guidewire perforation, hemopneumothorax, complete heart block, stent fracture, endocarditis, and early device dysfunction.No additional adverse patient effects were reported.

Manufacturer Narrative

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 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: 6333824
• MDR Text Key: 67534003
• Report Number: 2025587-2017-00254
• 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: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• 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: 01/17/2017
• 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