FDA Adverse Event Injury Summary report: N

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

MDR report key: 1253134 · Received December 5, 2008

Report

Report Number: 2134265-2008-04620
Event Type: Injury
Date Received: December 5, 2008
Date of Event: November 7, 2008
Report Date: November 10, 2008
Manufacturer: BOSTON SCIENTIFIC
Product Code: NIQ
PMA / PMN Number: P030025
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT EMBOLIZATION OCCURRED. THE 99% STENOSED LESION BEING TREATED WAS LOCATED IN THE NON-CALCIFIED, MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ATTEMPTED TO PLACE A 3.50X8MM TAXUS EXPRESS2 DRUG ELUTING STENT, BUT WAS UNABLE TO CROSS THE LESION, THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE FROM INSIDE THE PATIENT, BUT THE STENT CAUGHT ON TIP OF A GUIDE CATHETER, LOCATED IN THE OSTIUM OF THE RCA, AND DISLODGED. THE STENT WAS RETRIEVED USING A SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS STENT. PATIENT STATUS REPORTED AS "GOOD".

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	3.50X28 MM	11273572

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention