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

Model Number PB 10

Device Problems Fracture (1260); Gradient Increase (1270); Obstruction of Flow (2423)

Patient Problems Pulmonary Regurgitation (2023); Ventricular Tachycardia (2132); Stenosis (2263)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

Citation: boe ba et al.Leaflet morphology classification of the melody transcatheter pulmonary valve.Congenit heart dis.2019 mar; 14(2):297-304.Doi: 10.1111/chd.12728.Epub 2018 dec 13.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 regarding the leaflet morphology variations in the melody transcatheter pulmonary valve and an evaluation of the associated outcomes.All data were retrospectively collected from a single center between 2011 and 2016.The study¿s outcome analysis cohort included 55 patients and was predominantly male with a mean age of 22 years and a mean weight of 56 kg.All patients were implanted with medtronic melody transcatheter bioprosthetic valves in the pulmonary position.Of those, 2 were previously implanted with medtronic hancock valved conduits to repair the right ventricular outflow tract (rvot).No serial numbers were provided.Among all patients, one death occurred the day after the melody valve procedure in a patient with severe kyphoscoliosis and restrictive lung disease.It was reported that the patient developed respiratory arrest secondary to restrictive lung disease.The autopsy results showed severe hemorrhagic pulmonary edema and alveolar hemorrhage which likely lead to the respiratory failure.Based on the available information, medtronic product was not directly associated with the death.For both hancock patients, adverse events included: transcatheter valve-in-valve implantation due to pulmonary regurgitation, rvot obstruction, or a combination of both.Based on the available information, medtronic product was associated with the adverse events.Among all melody patients, adverse events included: surgical pulmonary valve replacement due to stenosis/unacceptable hemodynamic function and/or more than mild regurgitation (2 cases); transcatheter valve-in-valve implantation due to stent fracture (1 case); and surgical pulmonary valve replacement due to refractory ventricular arrhythmia (1 case).Based on the available information, medtronic product was associated with the adverse events.Among all melody patients, malfunctions included: stent fracture that did not require treatment or intervention (1 case).Based on the available information, medtronic product was associated with the malfunction.No additional adverse patient effects or product performance issues 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: 9682285
• MDR Text Key: 182007234
• Report Number: 2025587-2020-00409
• 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: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• 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: 01/28/2020
• 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: 22 YR
• Patient Weight: 56