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

Model Number PB 10

Device Problem Gradient Increase (1270)

Patient Problems Cardiovascular Insufficiency (4445); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449)

Event Date 01/04/2021

Event Type  Injury  

Event Description

Medtronic received information from a literature article regarding off-label surgical-hybrid implantation of the melody valve in the mitral position for small children.All data was collected between 2013 and 2019.The study population included seven patients (median age 6.7 months, median weight 5.8 kg).All patients were implanted with a medtronic melody transcatheter pulmonary valve in the mitral position.No unique device identifier numbers were provided.Prior to implantation, the authors noted that the melody valves were shortened from 28-30 mm to about 20 mm, by bending the distal and proximal stent struts backward, which facilitated implantation in the left heart.Of the seven patients, three deaths occurred.The first death was attributed to a ¿technical failure¿ in a case involving a 1.7-month-old patient (weight 4.7 kg) who experienced left ventricular outflow tract (lvot) obstruction during melody implantation.Intra-operative attempt to correct the obstruction led to left ventricular rupture and death.Based on the limited details provided in the article, the melody may have contributed to this death.The second death involved a patient who died due to acute respiratory distress syndrome eleven days after successful melody implant.The authors specified this death was unrelated to the melody.The third death pertained to a patient with acute myeloid leukemia who died of sepsis eleven months after valve implant, despite a well-functioning melody.No correlation was made between the melody and this death.Non-death adverse events included: heart transplantation due to left ventricular diastolic dysfunction two months after melody implant; melody valve protruding in the ventricular cavity causing a high lvot gradient, which reduced spontaneously after cessation of adrenaline and better preloading; transcatheter balloon dilation performed five months after melody implant for a pre-existing pulmonary vein ostial stenosis, which the authors stated was unrelated to the melody; transcatheter balloon dilation three years after melody implant to treat an elevated gradient; and trivial/mild regurgitation.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: vilius dranseika v, et al.Melody valve to replace the mitral valve in small children: lessons learned.Ann pediatr cardiol.Jan-mar 2021;14(1):35-41.Doi: 10.4103/apc.Apc_74_20.Epub 2021 jan 4.Earliest date of publish used for date of event.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 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.

• Brand Name: MELODY TRANSCATHETER PULMONARY VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13310209
• MDR Text Key: 284185310
• Report Number: 2025587-2022-00146
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• 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: 01/11/2022
• 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; Hospitalization
• Patient Age: 7 MO
• Patient Weight: 6 KG