FDA Adverse Event
Injury
Summary report: N
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
MDR report key: 4090349
·
Received September 15, 2014
Report
- Report Number
- 2025587-2014-00667
- Event Type
- Injury
- Date Received
- September 15, 2014
- Date of Event
- August 22, 2014
- Report Date
- August 22, 2014
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- LWR
- PMA / PMN Number
- P990064
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE PRODUCT BE RETURNED OR IF ADDITIONAL INFORMATION IS RECEIVED. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
MEDTRONIC RECEIVED INFORMATION THAT AN AORTIC BIOPROSTHETIC HEART VALVE WAS EXPLANTED AND WAS TO BE RETURNED TO MEDTRONIC. NO FURTHER INFORMATION REGARDING THE DEVICE OR PATIENT WAS REPORTED. IT WAS REPORTED THAT THE EXPLANTING FACILITY¿S RISK MANAGEMENT DEPARTMENT DECLINED TO PROVIDE ANY ADDITIONAL DETAILS REGARDING THE DEVICE AND PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568493 | MOSAIC AORTIC BIOPROSTHETIC HEART VALVE | HEART-VALVE, NON-ALLOGRAFT TISSUE | LWR | MEDTRONIC HEART VALVES DIVISION | 305U223 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |