TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Report

Report Number: 2134265-2010-05397
Event Type: Malfunction
Date Received: December 14, 2010
Date of Event: November 15, 2010
Report Date: November 16, 2010
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: P060008
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SE
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED A BREAK IN THE HYPOTUBE 490MM DISTAL TO THE CATHETER STRAIN RELIEF. THERE WERE ALSO KINKS IDENTIFIED ALONG THE ENTIRE LENGTH OF THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE SYSTEM. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. THE TIP, BALLOON AND STENT SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER ERROR AS THIS STENT WAS NOT INTENDED TO BE IMPLANTED IN A SAPHENOUS VEIN GRAFT, WHICH IS CONTRAINDICATED IN THE DFU. (B)(4).

Description of Event or Problem · 1

SAME CASE AS MFR# 2134265-2010-05526. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A SHAFT BREAK OCCURRED. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED, 3.5X15MM, CONCENTRIC AND RESTENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED SAPHENOUS VEIN GRAFT (SVG) TO THE RIGHT CORONARY ARTERY (RCA). IT WAS NOTED THAT A TAXUS LIBERTE STENT WAS IMPLANTED IN THE SVG TO THE RCA AT AN UNSPECIFIED TIME AND LATER BECAME RESTENOSED. THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON, LEAVING 30% RESIDUAL STENOSIS. THE PHYSICIAN ATTEMPTED TO ADVANCE A 4.50X24MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) FOR TREATMENT OF THE RESTENOSIS; HOWEVER THE DEVICE BECAME KINKED WHILE BEING ADVANCED OVER A NON BSC GUIDE WIRE AND THE SHAFT OF THE SDS BROKE INTO TWO PIECES. THE DEVICE NEVER ENTERED THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE.

Description of Event or Problem · 1

SAME CASE AS MFR# 2134265-2010-05526. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A SHAFT BREAK OCCURRED. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED, 3.5X15MM, CONCENTRIC AND RESTENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED SAPHENOUS VEIN GRAFT (SVG) TO THE RIGHT CORONARY ARTERY (RCA). IT WAS NOTED THAT A TAXUS LIBERTE STENT WAS IMPLANTED IN THE SVG TO THE RCA AT AN UNSPECIFIED TIME AND LATER BECAME RESTENOSED. THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON, LEAVING 30% RESIDUAL STENOSIS. THE PHYSICIAN ATTEMPTED TO ADVANCE A 4.50X24MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) FOR TREATMENT OF THE RESTENOSIS; HOWEVER THE DEVICE BECAME KINKED WHILE BEING ADVANCED OVER A NON BSC GUIDE WIRE AND THE SHAFT OF THE SDS BROKE INTO TWO PIECES. THE DEVICE NEVER ENTERED THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE.

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 - GALWAY	H7493894024450	12752053

Patients

Seq	Age	Sex	Outcome	Treatment
1	85 YR			LCB 6F GUIDE CATHETER\| BMW GUIDE WIRE