PROMUS ELEMENT ¿

Report

Report Number: 2134265-2012-07851
Event Type: Malfunction
Date Received: December 13, 2012
Date of Event: November 15, 2012
Report Date: November 17, 2012
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: SIMILAR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCT (B)(4).

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE REVEALED STENT DAMAGE. TWO STENT STRUTS FROM THE MIDDLE OF THE STENT WERE RAISED. THIS TYPE OF DAMAGE IS CONSISTENT WITH SOME FORM OF RESTRICTION HAVING OCCURRED. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. THE HYPOTUBE WAS KINKED ALONG ITS ENTIRE LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. CONTRAST MEDIA WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE LUMEN, THEREFORE INDICATING THAT THE DEVICE WAS PREPPED FOR USE. DURING ANALYSIS THE STENT WAS ABLE TO BE DEPLOYED WITHOUT ISSUE. NO ISSUES WERE NOTED WITH THE INNER SHAFT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE 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 CORONARY ARTERY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 80% STENOSIS AND WAS 25MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. A NON-BSC GUIDE WIRE WAS INTRODUCED WITH DIFFICULTY. TWO SUCCESSIVE DILATIONS WERE PERFORMED USING A 2.0X15MM MAVERICK BALLOON AND A 2.5X20MM MAVERICK BALLOON, LEAVING 30% RESIDUAL STENOSIS. THEN A 3.00X32MM PROMUS ELEMENT STENT WAS ADVANCED BUT COULD NOT BE IMPLANTED AFTER SEVERAL ATTEMPTS MOST PROBABLY DUE TO THE RESIDUAL CALCIFICATION. THE STENT WAS REMOVED AS THE PHYSICIAN THOUGHT IT MAY HAD BEEN DAMAGED. THEN A THIRD DILATION WAS PERFORMED USING THE PREVIOUS 2.5X20MM MAVERICK BALLOON WITH LONGER INFLATION TIME. FINALLY A 3.00X33MM NON-BSC STENT WAS IMPLANTED WITH CONSIDERABLE DIFFICULTY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS STABLE.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 80% STENOSIS AND WAS 25MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. A NON-BSC GUIDE WIRE WAS INTRODUCED WITH DIFFICULTY. TWO SUCCESSIVE DILATIONS WERE PERFORMED USING A 2.0X15MM MAVERICK BALLOON AND A 2.5X20MM MAVERICK BALLOON, LEAVING 30% RESIDUAL STENOSIS. THEN A 3.00X32MM PROMUS ELEMENT STENT WAS ADVANCED BUT COULD NOT BE IMPLANTED AFTER SEVERAL ATTEMPTS MOST PROBABLY DUE TO THE RESIDUAL CALCIFICATION. THE STENT WAS REMOVED AS THE PHYSICIAN THOUGHT IT MAY HAD BEEN DAMAGED. THEN A THIRD DILATION WAS PERFORMED USING THE PREVIOUS 2.5X20MM MAVERICK BALLOON WITH LONGER INFLATION TIME. FINALLY A 3.00X33MM NON-BSC STENT WAS IMPLANTED WITH CONSIDERABLE DIFFICULTY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS STABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROMUS ELEMENT ¿	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493911332300	14784643

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR			0.014 BMW GUIDE WIRE\| 3.00X33MM XIENCE STENT\| CLS3.5 RUNWAY GUIDE CATHETER