MELODY TRANSCATHETER PULMONARY VALVE PB 10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-02-07 for MELODY TRANSCATHETER PULMONARY VALVE PB 10 manufactured by Medtronic Heart Valves Division.

Event Text Entries

[181978483] 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 (b)(6) 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.
Patient Sequence No: 1, Text Type: N, H10


[181978484] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2025587-2020-00410
MDR Report Key9682274
Report SourceHEALTH PROFESSIONAL,LITERATUR
Date Received2020-02-07
Date of Report2020-02-07
Date of Event2018-12-13
Date Mfgr Received2020-01-28
Date Added to Maude2020-02-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA STREET NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC HEART VALVES DIVISION
Manufacturer Street1851 E DEERE AVE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal Code92705
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMELODY TRANSCATHETER PULMONARY VALVE
Generic NamePULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
Product CodeNPV
Date Received2020-02-07
Model NumberPB 10
Catalog NumberPB 10
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC HEART VALVES DIVISION
Manufacturer Address1851 E DEERE AVE SANTA ANA CA 92705 US 92705


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-07

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