FDA Adverse Event Injury Summary report: N

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

MDR report key: 1448367 · Received August 19, 2009

Report

Report Number: 2134265-2009-04081
Event Type: Injury
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" (ATTACHED) THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, INSTENT RESTENOSIS OCCURRED. THE UNPROTECTED LEFT MAIN (LM) ARTERY WAS STENTED WITH AN UNSPECIFIED TAXUS EXPRESS2 DRUG ELUTING STENT. SIX TO EIGHT MONTHS POST PROCEDURE IN-STENT RESTENOSIS WAS OBSERVED AND UNSPECIFIED TARGET LESION RE-INTERVENTION WAS PERFORMED. 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			Required Intervention