FDA Adverse Event
Injury
Summary report: N
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
MDR report key: 1306406
·
Received February 5, 2009
Report
- Report Number
- 2024168-2009-00178
- Event Type
- Injury
- Date Received
- February 5, 2009
- Date of Event
- January 5, 2009
- Report Date
- January 12, 2009
- 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
- MS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SECOND XIENCE V RX 3.0 X 28 MM (LOT# 7112661) IS BEING FILED UNDER THE SAME MANUFACTURER NUMBER.
Description of Event or Problem · 1
REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION . REPORTING RATIONALE: ANGINA AND DIAPHORESIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAD BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT THE PATIENT HAD PREVIOUSLY HAD TWO XIENCE V STENTS IMPLANTED. IN EARLY 2009, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST TIGHTNESS AND LEFT ARM PAIN. THE PATIENT ALSO HAD SOME DIAPHORESIS. AN ANGIOGRAPHY WAS PERFORMED AND THE PATENT WAS TREATED WITH PERCUTANEOUS CORONARY INTERVENTION (PTCI). 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 | 7112141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Hospitalization| R | LOT#7112661| XIENCE V RX 3.0X28 MM |