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 2020-02-05 for MELODY TRANSCATHER PULMONARY VALVE PB1018 manufactured by Medtronic Heart Valves Division.
[182000279]
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
[182000280]
Medtronic received information that following the implant of this transcatheter pulmonary bioprosthetic valve (tpbv), into a covered non-medtronic pre-stent, due to patient anatomy with recoil from the stent, the tpbv did not fully expand. A post-implant balloon aortic valvuloplasty was performed using a 22mm non-medtronic balloon. Three years, eleven months, twenty days following valve implant, multiple type ii stent fractures were noted with normal valve function. It was unknown if the fractures were present on the bioprosthetic valve or the covered stent. Per the physician, due to the retrosternal position of the stent and valve, with each heart beat the heart pushed the stent and valve against the sternum which eventually caused the stents to fracture. Five years, eleven months, twenty-one days following valve implant, a magnetic resonance imaging showed stenosis of the valve and reduced right ventricle function. Subsequently, seven years, eight months, twenty days following the valve implant a second tpbv was implanted valve-in-valve to protect right ventricle function. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-2020-00386 |
| MDR Report Key | 9672881 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-05 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2009-02-16 |
| Date Added to Maude | 2020-02-05 |
| 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 | 2020-02-05 |
| Model Number | PB1018 |
| Catalog Number | PB1018 |
| Device Expiration Date | 2013-09-06 |
| 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 | 2020-02-05 |