FDA Adverse Event Injury Summary report: N

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

MDR report key: 1032350 · Received April 22, 2008

Report

Report Number: 2134265-2008-01149
Event Type: Injury
Date Received: April 22, 2008
Date of Event: March 12, 2008
Report Date: March 28, 2008
Manufacturer: BOSTON SCIENTIFIC
Product Code: NIQ
PMA / PMN Number: P030025
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

AS NO DEVICE WAS RECEIVED FOR ANALYSIS IT IS NOT POSSIBLE TO PERFORM ANY INSPECTIONS ON THE DEVICE. AS THE BATCH NUMBER IS UNKNOWN A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CARRIED OUT. THE ROOT CAUSE WILL BE DOCUMENTED AS ANTICIPATED PROCEDURAL COMPLICATION DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE, AND/OR DEVICE LABELING.

Description of Event or Problem · 1

IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THROMBOSIS OCCURRED. A TAXUS EXPRESS2 DRUG ELUTING STENT, UNKNOWN SIZE, WAS IMPLANTED IN THE SAPHENOUS VEIN GRAFT (SVG) TO THE RIGHT CORONARY ARTERY (RCA). THE PATIENT DISCONTINUED PLAVIX IN 2008 AND PRESENTED WITH THROMBOSIS IN 2008. 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 SYSTEM	NIQ STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention