TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Report

Report Number: 6000089-2007-00174
Event Type: Death
Date Received: February 6, 2007
Date of Event: December 30, 2006
Report Date: January 8, 2007
Manufacturer: BOSTON SCIENTIFIC CORP.
Product Code: NIQ
PMA / PMN Number: p030025
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

A UNIT HAS NOT BEEN RETURNED FOR REVIEW, THEREFORE, A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. WITHOUT A RETURNED UNIT, IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH # 6863682 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION. THE ROOT CAUSE CANNOT BE IDENTIFIED.

Description of Event or Problem · 1

CLINICAL STUDY. IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PT EXPIRED. THE INDEX PROCEDURE TREATED A DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS 3.5 MM WIDE, 9 MM LONG, AND 80% STENOSED. THERE WAS MODERATE CALCIFICATION AND MILD TORTUOSITY. INTRAVASCULAR ULTRASOUND WAS PERFORMED PRIOR TO PREDILATION. THE PHYSICIAN THEN PLACED A 3.0 X 20 MM TAXUS EXPRESS2 STENT. POST DEPLOYMENT STENOSIS WAS O%. THE PT RECEIVED ANGIOMAX, ASPIRIN AND PLAVIX DURING THE PROCEDURE. THE PT WAS DISCHARGED ONE DAY LATER ON ASPIRIN AND PLAVIX. ON DAY 744, THE PT DIED DUE TO A MAJOR CEREBROVASCULAR ACCIDENT (CVA). THERE WAS NO AUTOPSY. IN THE OPINION OF THE PHYSICIAN, THERE WAS NO RELATIONSHIP BETWEEN THE DEATH AND THE TARGET VESSEL.

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 CORP.	3.0 X 20 MM	6863682

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR		Death