VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

Report

Report Number: 2134265-2010-04533
Event Type: Malfunction
Date Received: October 15, 2010
Date of Event: September 20, 2010
Report Date: September 21, 2010
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: MAF
PMA / PMN Number: P040016
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

RETURNED PRODUCT CONSISTED OF A LIBERTE OVER THE WIRE (OTW) STENT DELIVERY SYSTEM (SDS) WITH A GUIDE WIRE INSIDE THE DEVICE LUMEN AND NO STENT. BLOOD AND CONTRAST WERE VISIBLE IN THE DISTAL AND MIDSHAFT OF THE DEVICE WHICH IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS USED. THE DEVICE SOAKED OVERNIGHT IN A WATER BATH AND WAS NOT ABLE TO REMOVE THE GUIDE WIRE POSSIBLY DUE TO EXCESSIVE CONTRAST INSIDE THE DEVICE LUMEN. THE RETURNED CATHETER WAS VISUALLY AND TACTILELY EXAMINED ALONG THE ENTIRE LENGTH OF SHAFT AND NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. THE STENT IMPLANT WAS NOT PRESENT ON THE BALLOON OF THE SDS; HOWEVER, THERE WERE STENT STRUT IMPRESSIONS PRESENT ON THE SURFACE OF THE BALLOON BETWEEN THE MARKER BANDS, INDICATING THE STENT WAS APPROPRIATELY POSITIONED AND SECURED TO THE BALLOON IN MANUFACTURING. THE BALLOON WAS IN A LOOSELY FOLDED CONDITION, AS-RECEIVED, AND MICROSCOPIC EXAMINATION OF THE BALLOON PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES. 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

SAME CASE AS MFR# 2134265-2010-04534. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE CATHETER FROZE ON THE GUIDEWIRE. A KINETIX PLUS GUIDEWIRE WAS ADVANCED TO THE UNSPECIFIED LESION ALONG WITH A 4.50X28MM VERIFLEX STENT. THE VERIFLEX STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION; HOWEVER, WHEN THE PHYSICIAN WITHDREW THE STENT DELIVERY SYSTEM (SDS) FROM THE PATIENT, THE GUIDEWIRE CAME WITH IT AS BOTH DEVICES WERE STUCK TOGETHER. THE PROCEDURE WAS COMPLETED AT THIS POINT WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CONDITION IS FINE.

Description of Event or Problem · 1

SAME CASE AS MFR# 2134265-2010-04534. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE CATHETER FROZE ON THE GUIDEWIRE. A KINETIX PLUS GUIDEWIRE WAS ADVANCED TO THE UNSPECIFIED LESION ALONG WITH A 4.50X28MM VERIFLEX STENT. THE VERIFLEX STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION; HOWEVER, WHEN THE PHYSICIAN WITHDREW THE STENT DELIVERY SYSTEM (SDS) FROM THE PATIENT, THE GUIDEWIRE CAME WITH IT AS BOTH DEVICES WERE STUCK TOGETHER. THE PROCEDURE WAS COMPLETED AT THIS POINT WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CONDITION IS FINE.

Description of Event or Problem · 1

SAME CASE AS MFR# 2134265-2010-04534. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE CATHETER FROZE ON THE GUIDEWIRE. A KINETIX PLUS GUIDEWIRE WAS ADVANCED TO THE UNSPECIFIED LESION ALONG WITH A 4.50X28MM VERIFLEX STENT. THE VERIFLEX STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION; HOWEVER, WHEN THE PHYSICIAN WITHDREW THE STENT DELIVERY SYSTEM (SDS) FROM THE PATIENT, THE GUIDEWIRE CAME WITH IT AS BOTH DEVICES WERE STUCK TOGETHER. THE PROCEDURE WAS COMPLETED AT THIS POINT WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CONDITION IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM	STENT, CORONARY	MAF	BOSTON SCIENTIFIC - MAPLE GROVE	H7493893528450	13231365

Patients

Seq	Age	Sex	Outcome	Treatment
1				KINETIX PLUS GUIDEWIRE