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 2020-03-30 for EVOLUT R TRANSCATHETER AORTIC VALVE EVOLUTR-34-US manufactured by Medtronic Heart Valves Division.
[185601359]
Other relevant device(s) are: product id: envpro-16-us, serial/lot #: (b)(4), ubd: 24-jul-2021, udi#: (b)(4). Product analysis: the valve remains implanted and the delivery catheter system (dcs) was discarded, 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
[185601360]
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the patient became hemodynamically unstable following the first attempt to deploy the valve, which was partially deployed to 80%. The valve dislodged out of annular seating and was immediately recaptured. The patient? S pressures became unstable and remained that way without recovering despite advanced cardiovascular life support (acls) efforts. The valve was repositioned a second time and was fully deployed successfully, resulting in an optimal implant depth. The patient was closely monitored however the pressures remained sub-optimal. It was reported that the coronary embolization and left main coronary artery occlusion caused the patient to become hemodynamically unstable. Per the physician, the cause of the coronary occlusion was the embolization. The cause of the embolization was unknown. The patient was placed on cardiopulmonary bypass (cpb) and the procedure was converted to an open surgical procedure where the transcatheter valve was explanted. The patient died following the open surgical procedure. The cause of death was not reported. It is unknown whether an autopsy was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-2020-01008 |
| MDR Report Key | 9900208 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-08-05 |
| Date Added to Maude | 2020-03-30 |
| 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 R TRANSCATHETER AORTIC VALVE |
| Generic Name | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED |
| Product Code | NPT |
| Date Received | 2020-03-30 |
| Model Number | EVOLUTR-34-US |
| Catalog Number | EVOLUTR-34-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 | 2020-03-30 |