FDA Adverse Event
Death
Summary report: N
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
MDR report key: 1284991
·
Received January 9, 2009
Report
- Report Number
- 2024168-2009-00045
- Event Type
- Death
- Date Received
- January 9, 2009
- Date of Event
- December 9, 2008
- Report Date
- December 17, 2008
- Manufacturer
- ABBOTT VASCULAR-CARDIAC THERAPIES
- Product Code
- NIQ
- PMA / PMN Number
- P070015
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE OTHER XIENCE V EVEROLIMUS CORONARY STENT SYSTEM INDICATED ARE BEING FILED UNDER ANOTHER MFR NUMBER.
Description of Event or Problem · 1
REPORTING STATUS: DEATH. REPORTING RATIONALE: DEATH. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA TRIAL THAT THE INDEX PROCEDURE WAS PERFORMED IN 2008. THE PATIENT WAS TREATED WITH THE PLACEMENT OF TWO XIENCE V STENT IN THE DISTAL LAD. FORTY DAYS LATER, THE PATIENT EXPIRED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM | NIQ | ABBOTT VASCULAR-CARDIAC THERAPIES | NA | 8062361 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Death | (PART#1009539-12| STENT: XIENCE V EVEROLIMUS STENT SYSTEM |