FDA Adverse Event
Death
Summary report: N
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
MDR report key: 1242877
·
Received November 24, 2008
Report
- Report Number
- 2024168-2008-01224
- Event Type
- Death
- Date Received
- November 24, 2008
- Date of Event
- May 31, 2008
- Report Date
- October 29, 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
- HK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SECOND XIENCE V CORONARY STENT SYSTEM IS BEING FILED UNDER THE SAME MFR NUMBER.
Description of Event or Problem · 1
REPORTING STATUS: DEATH. REPORTING RATIONALE: DEATH. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA TRIAL THAT THE INDEX PROCEDURE TOOK PLACE IN 2007, DURING WHICH TWO XIENCE V STENTS WERE PLACED IN THE DISTAL AND MID LAD. NO DEVICE MALFUNCTION OR ADVERSE EVENTS WERE REPORTED DURING THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED BY THE HOSPITAL STATED THAT THE PATIENT'S WIFE CLAIMED THE PATIENT WAS FOUND EXPIRED WHILE SLEEPING IN 2008. CAUSE OF DEATH IN UNKNOWN. 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 | 72 YR | Death | STENT: XIENCE V CORONARY STENT SYSTEM| (PART# 1009527-18 LOT # UNK) |