MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-06 for MOSAIC AORTIC BIOPROSTHETIC HEART VALVE 30519 manufactured by Medtronic Heart Valves Division.
[144244578]
Citation: saxon j. Complications of bioprosthetic valve fracture as an adjunct to valve-in-valve tavr. Structural heart. 27 feb 2019; 3:2, 92-99, doi: 10. 1080/24748706. 2019. 1578446. Published online: 27 feb 2019. Earliest date of publication 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 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
[144244579]
Medtronic received information via literature regarding the use of and complications associated with bioprosthetic valve fracturing (bvf) to facilitate valve-in-valve transcatheter aortic valve replacement (viv tavr). All data were collected from case reports. The study population included 8 patients (predominantly female, mean age 76 years), 2 of which were implanted with medtronic mosaic valves (no serial numbers provided) and 6 received corevalve evolut r valves during viv tavr (no serial numbers provided). Among all mosaic valve patients, adverse events included: diastolic heart failure and aortic stenosis. Based on the available information medtronic product was directly associated with the adverse events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-2019-01478 |
| MDR Report Key | 8584598 |
| Date Received | 2019-05-06 |
| Date of Report | 2019-05-06 |
| Date of Event | 2019-02-27 |
| Date Mfgr Received | 2019-04-09 |
| Date Added to Maude | 2019-05-06 |
| 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 | 0 |
| Brand Name | MOSAIC AORTIC BIOPROSTHETIC HEART VALVE |
| Generic Name | TIMER, CLOT, AUTOMATED |
| Product Code | GKN |
| Date Received | 2019-05-06 |
| Model Number | 30519 |
| Catalog Number | 30519 |
| 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. Life Threatening; 2. Required No Informationntervention | 2019-05-06 |