FDA Adverse Event
Injury
Summary report: N
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
MDR report key: 1133304
·
Received August 22, 2008
Report
- Report Number
- 2024168-2008-00710
- Event Type
- Injury
- Date Received
- August 22, 2008
- Date of Event
- July 5, 2008
- Report Date
- July 25, 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
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: PLAQUE SHIFT REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED VIA A SPIRIT TRIAL, THAT THE XIENCE STENT WAS IMPLANTED IN THE 2ND OM. PLAQUE SHIFT WAS NOTED IN THE SIDE BRANCH. A CUTTING BALLOON WAS OPENED AND INSERTED INTO THE VASCULATURE; HOWEVER, IT WAS IMMEDIATELY REMOVED AND NOT USED TO REMOVE THE PLAQUE. BALLOON ANGIOPLASTY WAS PERFORMED ON THE SIDE BRANCH IN WHICH THE PLAQUE HAD SHIFTED TO. NO PT EFFECTS WERE REPORTED. NO ADD'L 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 | 71130P5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |