MAUDE Adverse Event Report: HEART VALVES SANTA ANA MELODY TRANSCATHER PULMONARY; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number PB1018

Device Problem Insufficient Information (3190)

Patient Problems Congenital Defect/Deformity (1782); Congestive Heart Failure (1783); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Ischemia (1942); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024); Tricuspid Regurgitation (2112); Pseudoaneurysm (2605)

Event Date 06/02/2016

Event Type  Injury  

Manufacturer Narrative

Citation: mohineesh kumar, md article title.Right ventricular outflow tract reconstruction with a polytetrafluoroethylene monocusp valve: a 20-year experience journal title.Semin thorac cardiovasc surg publish date: 2016: 28(2):463-470 10.1053/j.Semtcvs.2016.05.003 earliest date of publish used for event date in b3.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Separate medwatch reports are filed for each of the valves.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 patients with tetralogy of fallot (tof), pulmonary atresia (pa), and other congenital right ventricular outflow tract (rvot) malformations, using polytetrafluoroethylene (ptfe) monocusp outflow tract patches (motp) to relieve obstruction and provide pulmonary valve competence.All data were collected from a single center between 1994-2014.The study population included 171 patients (predominantly female, mean age 1.5 years), 21 of which were implanted with medtronic contegra, 5 were implanted with a medtronic freestyle, 4 were implanted with a medtronic melody and 2 were implanted with a medtronic mosaic (serial numbers not provided).Among all patients¿ adverse events included: arrhythmias, low cardiac output, bowelischemia, pleural effusion, reoperation, moderate or severe tricuspid regurgitation, severe pulmonary stenosis or severe pulmonary regurgitation, dilated right ventricle (rv), rv dysfunction and failure, pulmonary stenosis, endocarditis, residual ventricular septal defect (vsd), pseudoaneurysm, supravalvular or subvalvular stenosis, outgrowth and complete heart block (chb) with permanent pacemaker implant.Based on the available information, these events may have been attributed to medtronic product.No additional adverse patient effects or product performance issues were reported.

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): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): HEART VALVES SANTA ANA; 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: 6693735
• MDR Text Key: 79288487
• Report Number: 2025587-2017-01121
• 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: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 06/15/2017
• 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): Required Intervention
• Patient Age: 18 MO
• Patient Weight: 9