MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-30 for MELODY TRANSCATHETER PULMONARY VALVE PB 10 manufactured by Medtronic Heart Valves Division.
[185730748]
Citation: virk sa et al. Percutaneous pulmonary valve implantation: a systematic review of clinical outcomes. Int j cardiol. 2015 dec 15;201:487-9. Doi: 10. 1016/j. Ijcard. 2015. 08. 119. Epub 2015 aug 18. 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
[185730749]
Medtronic received information via literature regarding an assessment of the clinical outcomes in patients with right ventricular outflow tract (rvot) dysfunction who underwent percutaneous pulmonary valve implantation (ppvi). All data were collected from a meta-analysis systematic review of twelve studies between 2008 and 2014. The study population included 677 patients and was predominantly male with a mean age of 21 years. Of those, 602 were implanted with medtronic melody transcatheter pulmonary valves. No serial numbers were provided. Among all patients, 5 deaths were reported. Of those, an unidentified number may have been due to endocarditis (earliest case occurred at 1. 9 months after ppvi). Based on the available information, medtronic product may have been associated with the deaths. Among all patients, adverse events included: conversion to surgery; conduit rupture; endocarditis (earliest case occurred at 1. 9 months after ppvi); valve explant due to endocarditis; valve embolization; pulmonary artery obstruction; coronary artery compression; and restenosis and rvot reintervention due to stent fractures. Based on the available information, medtronic product was associated with the adverse events. Among all patients, malfunctions included: stent fractures that did not require intervention. Based on the available information, medtronic product was associated with the malfunctions. No additional adverse patient effects or product performance issues were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-2020-01012 |
| MDR Report Key | 9900403 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2015-08-18 |
| Date Mfgr Received | 2020-03-25 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| 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 | 2020-03-30 |