FDA Adverse Event
Injury
Summary report: N
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT
MDR report key: 782551
·
Received November 15, 2006
Report
- Report Number
- 6000093-2006-02353
- Event Type
- Injury
- Date Received
- November 15, 2006
- Report Date
- October 20, 2006
- Manufacturer
- BOSTON SCIENTIFIC CORP.
- Product Code
- NIQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DELIVERY DEVICE WAS DISCARDED BY THE HOSP AND THE STENT REMAINS IMPLANTED IN THE PT, THEREFORE, NO DIRECT PRODUCT ANALYSIS IS AVAILABLE. THE CAUSE OF THE DIFFICULTIES STATED IN THE COMPLAINT COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A THROMBOSIS OCCURRED.. "MALE PT HAD STOP USING PLAVIX FOR OVER SIX MONTHS POST PCI, BUT UNDER ONE YEAR FOR A SPINAL INJECTION. DO NOT KNOW WHEN THROMBOSIS OCCURRED, BUT THROMBOSED STENT LED TO AN MI. ES IS LESS THAN 20%." ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT | DRUG COATED STENT | NIQ | BOSTON SCIENTIFIC CORP. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |