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 2020-02-21 for MELODY TRANSCATHETER PULMONARY VALVE PB1016 manufactured by Medtronic Heart Valves Division.
[181993294]
(b)(4). Product analysis: the valve remains implanted therefore no product analysis can be performed. Conclusion: without return of the product, no definitive conclusion can be made regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[181993295]
Medtronic received information that one year nine months and twelve days following the implant of this transcatheter pulmonary bioprosthetic valve, following the admission for infective endocarditis, mild valve stenosis was observed. The endocarditis was successfully treated and no treatment for the stenosis was reported. Four years and three months post implant of the valve, protein losing enteropathy (ple) was reported and was caused by intestine inflammation and renal protein loss. No treatment was reported. Four years, four months and thirteen days following the valve implant, mild central valve regurgitation and mild valve stenosis was observed. No treatment was reported. Four years, five months and nine days following the valve implant, infective endocarditis, moderate central valve regurgitation with reduced left ventricular function was reported. It was unknown if the ple attributed to the infective endocarditis. Medication was given for the infective endocarditis. A second valve was implanted valve-in-valve due to increasing valvular regurgitation. It was unknown if the regurgitation was related to endocarditis. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-2020-00543 |
| MDR Report Key | 9741460 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-26 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2014-10-03 |
| Date Added to Maude | 2020-02-21 |
| 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 | 2020-02-21 |
| Model Number | PB1016 |
| Catalog Number | PB1016 |
| Device Expiration Date | 2016-06-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-02-21 |