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

Model Number PB 10

Device Problems Perivalvular Leak (1457); Appropriate Term/Code Not Available (3191)

Patient Problems Endocarditis (1834); Pulmonary Edema (2020); Pulmonary Regurgitation (2023); Tricuspid Regurgitation (2112); Ventricular Tachycardia (2132); Regurgitation (2259); Injury (2348)

Event Date 10/16/2017

Event Type  Injury  

Manufacturer Narrative

Citation: solana-gracia r pediatrics spanish registry of percutaneous melody pulmonary valve implantation in patients younger than 18 years.Rev esp cardiol (engl ed).2018 apr;71(4):283-290.Doi: 10.1016/j.Rec.2017.07.013.Epub 2017 oct 16.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.  without the 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.

Event Description

Medtronic received information via literature from pediatrics spanish registry on percutaneous melody pulmonary valve implantation in patients younger than 18 years.All data were collected from multiple centers between march 2007 and january 2017.Eighty one medtronic melody valves were implanted in 77 patients (predominantly male, median age 13 years).One patient underwent a double implantation because he had a double right ventricular outflow tract (rvot) (conduit + native rvot) and 3 patients required a second melody valve (2 via the valve-in-valve technique and the other after explantation of the initial valve and surgical reconstruction of the rvot).One patient had a previously implanted contegra valved conduit.No serial numbers were provided.Among all patients, 1 death occurred due to infective endocarditis.The time from implant to infection was not clearly stated for this patient; however, per table 4 the shortest time frame could have been 100 days post-implant.Insufficient information received to reasonably suggest that the device caused/contributed to a reportable event.Among all patients, adverse events included: iatrogenic aortopulmonary window and tricuspid valve injury requiring intervention, moderate tricuspid regurgitation, ventricular tachycardia, mild paravalvular leak (pvl), pulmonary edema, severe pulmonary regurgitation requiring reintervention with balloon dilation, or valve-in-valve, endocarditis requiring surgical extraction of the valve.Based on the available information, medtronic product may have caused or contributed to these adverse events.Among all patients, adverse events related to ensemble delivery system included: femoral thrombosis.Among all patients, adverse events related to contegra included: endocarditis.Among all patients, device malfunctions related to melody included: stent fracture.Based on the available information, this malfunction may have been attributed to medtronic product.No additional adverse patient effects or product performance problems were reported.

• Brand Name: MELODY TRANSCATHETER 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: 7847895
• MDR Text Key: 119318558
• Report Number: 2025587-2018-02342
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 08/16/2018
• 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: 13 YR
• Patient Weight: 46