FDA Adverse Event
Injury
Summary report: N
EVOLUT R TRANSCATHETER AORTIC VALVE
MDR report key: 6170613
·
Received December 13, 2016
Report
- Report Number
- 2025587-2016-02006
- Event Type
- Injury
- Date Received
- December 13, 2016
- Date of Event
- November 22, 2016
- Report Date
- November 22, 2016
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- UDI-DI
- 00643169638006
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION.
Additional Manufacturer Narrative · 1
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 29 MM TRANSCATHETER BIOPROSTHETIC VALVE, DUE TO A SEPTAL BULGE, THE VALVE MOVED AORTIC UPON RELEASE RESULTING IN SEVERE PARAVALVULAR LEAK (PVL). A SECOND VALVE WAS SUCCESSFULLY IMPLANTED IN A DEEPER POSITION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 822156 | EVOLUT R TRANSCATHETER AORTIC VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | MEDTRONIC HEART VALVES DIVISION | EVOLUTR-29-US | 00643169638006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |