FDA Adverse Event Malfunction Summary report: N

TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

MDR report key: 1880090 · Received October 22, 2010

Report

Report Number: 2134265-2010-04614
Event Type: Malfunction
Date Received: October 22, 2010
Date of Event: September 30, 2010
Report Date: September 30, 2010
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: NIQ
PMA / PMN Number: P060008
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4)- IT IS 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, BALLOON WITHDRAWAL RESISTANCE OCCURRED. THE SMALL TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 24X2.25MM TAXUS LIBERTE ATOM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS DEPLOYED AT 14ATMS. THE DELIVERY BALLOON INFLATED WITHOUT WAIST AND WAS DEFLATED WITHOUT ANY ISSUE. HOWEVER, UPON REMOVING THE DELIVERY SYSTEM THERE WAS A "STICKING ISSUE" AND THE PHYSICIAN HAD TO MANIPULATE THE BALLOON TO GET IT TO RELEASE. THE SDS WAS REMOVED INTACT AND THE STENT WAS NOT AFFECTED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM	CORONARY DRUG-ELUTING STENT	NIQ	BOSTON SCIENTIFIC - MAPLE GROVE	H7493893624220	13084410

Patients

Seq	Age	Sex	Outcome	Treatment
1