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.
[182007234]
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.
Patient Sequence No: 1, Text Type: N, H10
[182007235]
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
| Report Number | 2025587-2020-00409 |
| MDR Report Key | 9682285 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date of Event | 2018-12-13 |
| Date Mfgr Received | 2020-01-28 |
| Date Added to Maude | 2020-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC HEART VALVES DIVISION |
| Manufacturer Street | 1851 E DEERE AVE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92705 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MELODY TRANSCATHETER PULMONARY VALVE |
| Generic Name | PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED |
| Product Code | NPV |
| Date Received | 2020-02-07 |
| Model Number | PB 10 |
| Catalog Number | PB 10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC HEART VALVES DIVISION |
| Manufacturer Address | 1851 E DEERE AVE SANTA ANA CA 92705 US 92705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-07 |