FDA Adverse Event
Injury
Summary report: N
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
MDR report key: 1552628
·
Received December 4, 2009
Report
- Report Number
- 2024168-2009-02284
- Event Type
- Injury
- Date Received
- December 4, 2009
- Date of Event
- May 19, 2008
- Report Date
- November 10, 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
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE OTHER XIENCE V STENT MENTIONED IS BEING FILED UNDER THE SAME MFR NUMBER.
Description of Event or Problem · 1
REPORTING STATUS: SERIOUS INJURY - PERMANENT DAMAGE. REPORTING RATIONALE: PROCEDURAL MYOCARDIAL INFARCTION (MI) RESULTING IN PERMANENT DAMAGE. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT A 2.5 X 18 XIENCE WAS IMPLANTED IN THE OM2 AND A 3.0 X 23 XIENCE WAS IMPLANTED IN THE PROXIMAL LAD. THE PATIENT EXPERIENCED A PERI-PROCEDURAL MYOCARDIAL INFARCTION (MI) WITH CKMB RAISED AT 40.6 NG/ML AT 24 H. 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Disability | PART # 1009527-18, LOT # UNK| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM |