FDA Adverse Event
Malfunction
Summary report: N
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
MDR report key: 1243128
·
Received November 21, 2008
Report
- Report Number
- 2024168-2008-01201
- Event Type
- Malfunction
- Date Received
- November 21, 2008
- Date of Event
- October 21, 2008
- Report Date
- October 24, 2008
- Manufacturer
- ABBOTT VASCULAR-CARDIAC THERAPIES
- Product Code
- NIQ
- PMA / PMN Number
- P070015
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SECOND XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS BEING FILED UNDER THE SAME MFR #.
Description of Event or Problem · 1
REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: DISLODGED STENT HAS PREVIOUSLY CAUSED OR CONTRIBUTED TO PT INJURY. DEVICE ISSUE: DISLODGED STENT. IT WAS REPORTED THAT THE 2.5X18MM AND THE 2.75X15MM XIENCE DEVICES FAILED TO CROSS THE LESION AND UPON RETRACTION THE STENTS DISLODGED INSIDE THE GUIDING CATHETER AND WERE REMOVED FROM THE PT'S BODY WITHOUT FURTHER INCIDENT. NO PT EFFECTS WERE REPORTED. 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 | UNK | STENT: XIENCE V EVEROLIMUS ELUTING CORONARY| STENT SYSTEM (PART# 1009540-15 |