MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-30 for COREVALVE TRANSCATHETER AORTIC VALVE CRS manufactured by Medtronic Heart Valves Division.
[185918488]
Citation: abdel-wahab m et al. Basilica for a degenerated self-expanding transcatheter heart valve: structural considerations for supra-annular prosthetic leaflets. Jacc cardiovasc interv. 2020 mar 23;13(6):778-781. Doi: 10. 1016/j. Jcin. 2019. 10. 008. Epub 2020 feb 26. Earliest date of publish used for event date. No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported. Without the return of the product, no definitive conclusion can be made regarding the clinical observations. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185918489]
Medtronic received information via a literature case report regarding a male patient who underwent transcatheter aortic valve replacement (tavr) with a 29 mm medtronic corevalve transcatheter bioprosthetic valve (serial number not provided) for severe aortic stenosis. Seven years later (at (b)(6) years of age), the patient presented with structural valve deterioration due to stenosis and moderate aortic regurgitation was observed on aortography. Consequently, redo tavr was performed. During the procedure, an electrosurgical generator system was used to lacerate the corevalve? S left coronary leaflet to prevent coronary obstruction and facilitate coronary access when the new transcatheter valve was implanted inside the degenerated corevalve. Following laceration, the left coronary leaflet was retrieved from the patient? S left ventricle with a snare. Immediately afterward, a 26 mm non-medtronic transcatheter bioprosthetic valve was implanted valve-in-valve. No additional adverse patient effects or product performance issues were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-2020-01015 |
| MDR Report Key | 9901148 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-03-25 |
| 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 | COREVALVE TRANSCATHETER AORTIC VALVE |
| Generic Name | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED |
| Product Code | NPT |
| Date Received | 2020-03-30 |
| Model Number | CRS |
| Catalog Number | CRS |
| 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. Required No Informationntervention | 2020-03-30 |