LIBERTE' CORONARY STENT DELIVERY SYSTEM

Report

Report Number: 2134265-2010-03066
Event Type: Malfunction
Date Received: July 16, 2010
Date of Event: April 2, 2010
Report Date: June 22, 2010
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: MAF
PMA / PMN Number: P040016
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE CRIMPED STENT HAD SOME OF ITS STRUTS BENT BACK DISTALLY AT THE PROXIMAL END OF THE STENT. NO OTHER ISSUES EXISTED WITH THIS DEVICE. THERE WERE NO KINKS NOTED ALONG THE ENTIRE LENGTH OF THE SHAFT. A 0.015 INCH SIZE PRODUCT MANDREL WAS INSERTED THROUGH THE TIP AND WIRE LUMEN WITH NO RESTRICTIONS NOTED. 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

REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, CROSSING DIFFICULTY OCCURRED. THE 70 - 80% STENOSED LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS MID TO DISTAL LEFT CIRCUMFLEX ARTERY. AFTER THE PHYSICIAN PERFORMED PRE-DILATATION WITH AN UNSPECIFIED BALLOON CATHETER, HE ATTEMPTED TO CROSS THE LESION WITH A 2.5 X 16MM LIBERTE BARE METAL STENT. THE STENT WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED BARE METAL STENT. RETURNED PRODUCT ANALYSIS REVEALED STENT DAMAGE. NO PATIENT COMPLICATIONS OCCURRED. THE PATIENT STATUS WAS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LIBERTE' CORONARY STENT DELIVERY SYSTEM	STENT, CORONARY	MAF	BOSTON SCIENTIFIC - GALWAY	H7493893816250	12864174

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR