FDA Adverse Event
Death
Summary report: N
WINGSPAN STENT SYSTEM
MDR report key: 1081217
·
Received July 22, 2008
Report
- Report Number
- 2939204-2008-00295
- Event Type
- Death
- Date Received
- July 22, 2008
- Date of Event
- June 11, 2006
- Report Date
- November 6, 2007
- Manufacturer
- BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION
- Product Code
- NJE
- PMA / PMN Number
- H050001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UNK AS THE MODEL AND LOT NUMBER WAS NOT DISCLOSED. NO DEVICE MALFUNCTION WAS ALLEGED.
Description of Event or Problem · 1
IT WAS REPORTED THE PT UNDERWENT TREATMENT WITH A STENT FOR INTRACRANIAL ATHEROSCLEROTIC DISEASE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) IN 2006. PRE-PROCEDURE STENOSIS WITH THROMBUS WAS 100% OCCLUDED, RESIDUAL STENOSIS POST PROCEDURE WAS 0%. ABOUT 5 DAYS POST PROCEDURE, THE PT SUFFERED AN INTRACRANIAL HEMORRHAGE AND SUBSEQUENTLY EXPIRED THE SAME DAY. THE PT'S CAUSE OF DEATH WAS DETERMINED TO BE THE RESULT OF THE INTRACRANIAL HEMORRHAGE, HOWEVER, THE CAUSE OF THE HEMORRHAGE IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WINGSPAN STENT SYSTEM | (NJE) INTRAVASCULAR STENT | NJE | BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Death |