MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-13 for MOSAIC AORTIC BIOPROSTHETIC HEART VALVE 305C manufactured by Heart Valves Santa Ana.
[67319775]
The device has not been received for analysis. Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation. The device serial number has not been received. Without the serial number, the device manufacturing date, expiration date, and the unique device identifier may remain unknown.
Patient Sequence No: 1, Text Type: N, H10
[67319776]
Medtronic received information that post implant (duration unknown) of this bioprosthetic valve, it was explanted and replaced due to continued aortic insufficiency and stenosis. No other adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[98776644]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2025587-2017-00236 |
| MDR Report Key | 6327791 |
| Date Received | 2017-02-13 |
| Date of Report | 2017-01-24 |
| Date of Event | 2017-01-24 |
| Date Mfgr Received | 2017-01-24 |
| Date Added to Maude | 2017-02-13 |
| 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 | HEART VALVES SANTA ANA |
| 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 | 2017-02-13 |
| Model Number | 305C |
| Catalog Number | 305C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEART VALVES SANTA ANA |
| Manufacturer Address | 1851 E DEERE AVE SANTA ANA CA 92705 US 92705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-13 |