MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-22 for MELODY TRANSCATHETER PULMONARY VALVE PB 10 manufactured by Medtronic Heart Valves Division.
[176383762]
Citation: georgiev s et al. A low residual pressure gradient yields excellent long-term outcome after percutaneous pulmonary valve implantation. Jacc: cardiovascular interventions. 2019; 12(16):1594-1603. Doi: 10. 1016/j. Jcin. 2019. 03. 037. 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 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
[176383763]
Medtronic received information via literature regarding a prospective study into the long-term effectiveness of percutaneous pulmonary valve implants (ppvi). All data were collected from a single center between december 2006 and december 2017. The study population included 226 patients (unknown male/female distribution, median age 18 years, median weight 59kg), 220 of which were implanted with medtronic melody ppvis, 17 with medtronic contegra conduits, and 12 with medtronic hancock conduits (no serial numbers provided). Among all patients, 7 deaths occurred. Two of the deaths occurred from procedure-related complications, one from conduit rupture leading to severe bleeding and one from left coronary artery compression. One death occurred at 8 months post implant of the ppvi, likely due to a rhythm disturbance caused by low potassium levels. Four deaths occurred at 3 years to 7 years post implant of the ppvi for unknown reasons but possibly due to rhythm disturbances. No further details about the deaths were provided, and multiple manufacturer? S products were mentioned in the literature. Based on the available information medtronic product was not directly associated with the deaths. Among all medtronic melody patients, adverse events included: infective endocarditis, valve degeneration (stenosis), severe pulmonary regurgitation, elevated gradients. A total of 17 patients required intervention to replace the ppvi. Based on the available information medtronic product was directly associated with the adverse events. No additional adverse patient effects or product performance issues were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-2020-00238 |
| MDR Report Key | 9617826 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-22 |
| Date of Event | 2019-06-12 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-01-22 |
| 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 | 2020-01-22 |
| 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 | 2020-01-22 |