FDA Adverse Event Death Summary report: N

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

MDR report key: 1445149 · Received August 19, 2009

Report

Report Number: 2134265-2009-04062
Event Type: Death
Date Received: August 19, 2009
Date of Event: May 5, 2009
Report Date: July 21, 2009
Manufacturer: BOSTON SCIENTIFIC
Product Code: NIQ
PMA / PMN Number: P030025
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. LITERATURE CITATION: UNPROTECTED LEFT MAIN STENTING IN THE REAL WORLD: TWO-YEAR OUTCOMES OF THE FRENCH LEFT MAIN TAXUS REGISTRY. CIRCULATION 2009; 119(17): 2349-56. VAQUERIZO B, LEFEVRE T, DARREMONT O, SILVESTRI M, LOUVARD Y, LEYMARIE JL, ET AL.

Description of Event or Problem · 1

IT WAS REPORTED IN THE JOURNAL ARTICLE TITLED, "UNPROTECTED LEFT MAIN STENTING IN THE REAL WORLD: TWO-YEAR OUTCOMES OF THE FRENCH LEFT MAIN TAXUS REGISTRY" THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, ACUTE STENT THROMBOSIS AND PT DEATH OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE DISTAL LEFT MAIN (LM) AND WAS 90% STENOSED. THE PT SUSTAINED A FATAL PERI-PROCEDURE STENT THROMBOSIS. NO FURTHER INFO IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM	NIQ STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR		Death