FDA Adverse Event
Death
Summary report: N
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
MDR report key: 1210993
·
Received October 24, 2008
Report
- Report Number
- 2024168-2008-01014
- Event Type
- Death
- Date Received
- October 24, 2008
- Date of Event
- September 5, 2008
- Report Date
- September 26, 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
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTING STATUS: SERIOUS INJURY. REPORTING RATIONALE: DEATH. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA TRIAL THAT IN 2008, THE PT DIED. BASED ON LIMITED INFO, THIS EVENT IS BEING CONSERVATIVELY FILED AS A DEATH MDR. NO ADDITIONAL EVENT OR PT INFO 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Death| H| R |