FDA Adverse Event Malfunction Summary report: N

TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

MDR report key: 1896835 · Received November 11, 2010

Report

Report Number: 2134265-2010-04932
Event Type: Malfunction
Date Received: November 11, 2010
Date of Event: October 13, 2010
Report Date: October 15, 2010
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: P060008
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER- IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT DISLODGED OUTSIDE THE PATIENT. THE TARGET LESION WAS LOCATED IN THE TORTUOUS CIRCUMFLEX ARTERY (CX). THE LESION WAS PREDILATED WITH A 2.5X15MM APEX BALLOON. THEN A 28X2.25MM TAXUS LIBERTE ATOM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT WOULD NOT CROSS THE LESION. THE DEVICE WAS REMOVED AND THE SCRUB TECHNICIAN WIPED DOWN THE CATHETER AND THE STENT SLIPPED OFF THE DELIVERY BALLOON AND ONTO THE TABLE. THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY. 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 ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM	CORONARY DRUG-ELUTING STENT	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493893628220	12702717

Patients

Seq	Age	Sex	Outcome	Treatment
1				2.5 X 15MM APEX BALLOON