FDA Adverse Event
Injury
Summary report: N
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
MDR report key: 1312348
·
Received February 12, 2009
Report
- Report Number
- 2024168-2009-00233
- Event Type
- Injury
- Date Received
- February 12, 2009
- Date of Event
- November 25, 2008
- Report Date
- January 23, 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
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
REPORTING STATUS: SERIOUS INJURY/PERMANENT DAMAGE. REPORTING RATIONALE: OCCLUSION RESULTING IN PERMANENT DAMAGE. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA TRIAL THAT ONE DAY FOLLOWING STENTING OF THE CFX/OM WITH A XIENCE STENT, WHICH WAS A BIFURCATION LESION; THERE WAS A SUBTOTAL OCCLUSION OF A SMALL TRIFURCATION BRANCH. THE PT'S CARDIAC ENZYMES WERE ELEVATED, BUT THERE WAS NO COMPLAINT OF PAIN, NO EKG CHANGES AND NO DIAGNOSIS OF MYOCARDIAL INFARCTION. THERE WAS NO TREATMENT REPORTED AND THE PT WAS DISCHARGED THE SAME DAY. 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 | 8061661 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Disability |