FDA Adverse Event
Injury
Summary report: N
WINGSPAN STENT SYSTEM
MDR report key: 1081307
·
Received July 22, 2008
Report
- Report Number
- 2939204-2008-00296
- Event Type
- Injury
- Date Received
- July 22, 2008
- Date of Event
- February 2, 2007
- Report Date
- October 1, 2007
- Manufacturer
- BOSTON SCIENTIFIC, NEUROVASCULAR DIV.
- Product Code
- NJE
- PMA / PMN Number
- H050001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS LOT NUMBER WAS NOT DISCLOSED. (OTHER) - NO DEVICE MALFUNCTION WAS ALLEGED.
Description of Event or Problem · 1
THE PT UNDERWENT TREATMENT WITH A STENT FOR INTRACRANIAL ATHEROSCLEROTIC DISEASE IN THE RIGHT CAROTID OPHTHALMIC ARTERY IN EARLY 2006. PRE-PROCEDURE STENOSIS WAS 90%, RESIDUAL STENOSIS POST PROCEDURE WAS 20%. NO COMPLICATIONS WERE REPORTED. DURING A FOLLOW-UP EVALUATION IN 2007, IT WAS REPORTED THE PT SUFFERED A TIA. PT WAS TREATED WITH MEDICATIONS (TYPE AND DOSAGE UNK) AND HOSPITALIZATION. AT THE TIME DISCHARGE EFFECTS WERE REPORTED TO BE ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WINGSPAN STENT SYSTEM | (NJE) INTRAVASCULAR STENT | NJE | BOSTON SCIENTIFIC, NEUROVASCULAR DIV. | WS035015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Hospitalization| R |