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 2020-01-08 for MELODY TRANSCATHER PULMONARY VALVE PB1018 manufactured by Medtronic Heart Valves Division.
[174172598]
Product analysis: the device remains implanted, therefore no product analysis can be performed. Conclusion: without the 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
[174172599]
Medtronic received information that four years, nine months and six days following the implant of this transcatheter pulmonary bioprosthetic valve without pre-stenting, patient outgrowth of the device revealed stenosis. Intervention was required for the stenosis. A dilation was occurred with a high-pressure balloon. The dilation revealed a stent fracture of the valve and required the implant of a stent and a second transcatheter pulmonary bioprosthetic valve. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-2020-00082 |
| MDR Report Key | 9565159 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-08 |
| Date of Report | 2020-02-07 |
| Date of Event | 2011-09-20 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2006-04-28 |
| Date Added to Maude | 2020-01-08 |
| 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 TRANSCATHER PULMONARY VALVE |
| Generic Name | PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED |
| Product Code | NPV |
| Date Received | 2020-01-08 |
| Model Number | PB1018 |
| Catalog Number | PB1018 |
| Device Expiration Date | 2007-04-28 |
| 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 | 2020-01-08 |