MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for EVOLUT PRO TRANSCATHETER AORTIC VALVE EVOLUTPRO-26-US manufactured by Medtronic Heart Valves Division.
[185721509]
Other relevant device(s) are: product id: e vproplus-26us, serial/lot #: (b)(4), ubd: 09-jan-2022, udi#: (b)(4); product id: d-evprop2329us, serial/lot #: (b)(4), ubd: 13-jan-2021, udi#: (b)(4). Product analysis: the delivery catheter system (dcs) was discarded and the valves were not returned, 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
[185721510]
Medtronic received information that during the implant of this transcatheter bioprosthetic valve; while retrieving the delivery catheter system (dcs) from the patient, the nose cone caught on the valve and dislodge the valve. A second valve was placed and was prematurely deployed causing the patient to become decompensated. The patient was converted to surgical aortic valve repair and both transcatheter bioprosthetic valves were explanted. It was reported that the patient died during the procedure. The cause of death was not received and it is unknown if an autopsy was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-2020-01031 |
| MDR Report Key | 9903607 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-24 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2018-06-22 |
| Date Added to Maude | 2020-03-31 |
| 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 | EVOLUT PRO TRANSCATHETER AORTIC VALVE |
| Generic Name | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED |
| Product Code | NPT |
| Date Received | 2020-03-31 |
| Model Number | EVOLUTPRO-26-US |
| Catalog Number | EVOLUTPRO-26-US |
| 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. Death | 2020-03-31 |