BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1844239 · Received September 24, 2010

    Report

    Report Number
    2134265-2010-04475
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    November 1, 2007
    Report Date
    September 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT.DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4)

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MFR ID: 2134265-2010-04474. SAME PATIENT AS MFR ID: 2134265-2010-04379, 2134265-2010-04380. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, IN STENT RESTENOSIS OCCURRED. IN (B)(4)-2005, DUE TO ATYPICAL CHEST PAIN, THE PATIENT UNDERWENT CARDIAC CATHETERIZATION. ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY. THREE LESIONS WERE TREATED AT THIS PROCEDURE. A TUBULAR 85% STENOSED, 10MM LONG, CONCENTRIC, TYPE "B1" LESION WAS LOCATED IN THE MILDLY CALCIFIED MID SECOND OBTUSE MARGINAL (OM2) WITH TIMI-3 FLOW. AN 8F 100CM NON BSC GUIDE CATHETER WAS ADVANCED FOLLOWED BY A 0.014" 190CM NON BSC GUIDE WIRE THAT WAS USED TO CROSS THE OM2. A 2.5X12MM TAXUS EXPRESS2 STENT WAS ADVANCED AND REMOVED. A 2.5X12MM MAVERICK2 BALLOON WAS USED TO PREDILATE THE LESION AT 8ATM FOR 60 SECONDS. THE 2.5X12MM TAXUS EXPRESS2 STENT DELIVERY SYSTEM WAS AGAIN ADVANCED AND WAS DEPLOYED AT 12ATM FOR 45 SECONDS. ADDITIONAL POST DILATION PERFORMED WITH THE STENT BALLOON AT 2ATM FOR 10 SECONDS RESULTING IN 0% RESIDUAL STENOSIS. TIMI-3 FLOW WAS MAINTAINED. THE STENT DELIVERY SYSTEM BALLOON WAS REMOVED. THE SECOND LESION TREATED WAS A TUBULAR 80% STENOSED, 20MM LONG, CONCENTRIC, TYPE "B1" LESION IN THE MILDLY CALCIFIED PROXIMAL FIRST OBTUSE MARGINAL (OM1) WITH TIMI-3 FLOW. THE NON BSC GUIDE WIRE WAS THEN ADVANCED DOWN THE LCX ALONG WITH ANOTHER 0.014" 180CM NON BSC GUIDE WIRE THAT WAS DIRECTED TO THE OM1. A 2.5X12MM MAVERICK2 BALLOON WAS ADVANCED INTO THE OM1 AND USED TO PREDILATE THE LESION AT 2 INFLATIONS TO 6ATM, 20 SECONDS AND 10 SECONDS. THE 2.5X24MM TAXUS EXPRESS2 STENT WAS THEN ADVANCED AND DEPLOYED IN THE OM1 AT 9ATM FOR 30 SECONDS. A 2.5X12MM MAVERICK BALLOON WAS USED TO POST DILATE THE STENT AT 16ATM FOR 15 SECONDS RESULTING IN 0% RESIDUAL STENOSIS. TIMI-3 FLOW WAS MAINTAINED. THE THIRD LESION TREATED WAS A 70% STENOSED, 20MM LONG, CONCENTRIC, TYPE "B1" LESION LOCATED IN THE MILDLY CALCIFIED PROXIMAL LEFT CIRCUMFLEX (LCX) WITH TIMI-3 FLOW. A NON BSC GUIDE WIRE WAS ADVANCED DOWN THE LCX. A 2.5X12MM MAVERICK2 BALLOON WAS ADVANCED AND PREDILATED THE LESION AT 12ATM FOR 30 SECONDS. A 3.0X20MM TAXUS EXPRESS2 STENT WAS ADVANCED TO THE LESION AND DEPLOYED AT 12ATM FOR 20 SECONDS. ANOTHER NON BSC 0.014" 180CM GUIDE WIRE WAS ADVANCED DOWN THE OM1 AND A 2.5X12MM MAVERICK2 BALLOON WAS INFLATED AT 8ATM FOR 15 SECONDS. THE TAXUS EXPRESS2 STENT DELIVERY SYSTEM BALLOON WAS ADVANCED ALONG WITH A 2.5X15MM MAVERICK2 BALLOON FOR A KISSING BALLOON TECHNIQUE. THE MAVERICK2 BALLOON WAS INFLATED AT 8ATM FOR 15 SECONDS. FINAL RESULT WAS 0% RESIDUAL STENOSIS AND TIMI-3 FLOW WAS MAINTAINED. THE PROCEDURE WAS CLOSED WITHOUT PATIENT COMPLICATIONS. IN (B)(6)-2007, DUE TO ATYPICAL CHEST PAIN, THE PATIENT UNDERWENT CARDIAC CATHETERIZATION. THE PREVIOUSLY PLACED STENTS WERE FOUND TO BE PATENT. HOWEVER, A NEW LESION WAS IDENTIFIED. A 70% STENOSED, 10MM LONG, ECCENTRIC, "HIGH RISK" LESION WAS LOCATED IN THE MODERATELY CALCIFIED LEFT MAIN CORONARY ARTERY (LMCA) WITH TIMI-3 FLOW. IT WAS TREATED WITH PLACEMENT OF A 3.0X16MM TAXUS EXPRESS2 STENT RESULTING IN 0% RESIDUAL STENOSIS AND TIMI-3 FLOW WAS MAINTAINED. THERE WERE NO PATIENT COMPLICATIONS REPORTED DURING THE PROCEDURE. IN (B)(6)-2007, DUE TO ATYPICAL CHEST PAIN AND DYSPNEA ON EXERTION, THE PATIENT RETURNED FOR CARDIAC CATHETERIZATION. A 75% STENOSED, 5MM LONG, ECCENTRIC AND HIGH RISK LESION WAS IDENTIFIED IN THE SEVERELY CALCIFIED MID LMCA WITH TIMI-3 FLOW. IT WAS TREATED WITH AN UNKNOWN SIZE TAXUS EXPRESS2 STENT RESULTING IN 0% RESIDUAL STENOSIS AND TIMI-3 FLOW WAS MAINTAINED. A 70% STENOSED, 5MM LONG, CONCENTRIC, NON-HIGH RISK LESION WAS IDENTIFIED IN THE MILDLY CALCIFIED OSTIAL 1ST OM WITH TIMI-3 FLOW. IT WAS TREATED WITH PLAIN OLD BALLOON ANGIOPLASTY (POBA) RESULTING IN 0% RESIDUAL STENOSIS AND TIMI-3 FLOW WAS MAINTAINED. THERE WERE NO PATIENT COMPLICATIONS REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R CORDIS 6F 100CM SUPER TORQUE IMA CATHETER X2| 8F 10CM PINNACLE SHEATH| CORDIS 6F 100CM JR 4.0 GUIDE CATHETER| 0.014"190CM PILOT 50 WIRE| 2.5X15MM MAVERICK2 BALLOON| 2.5X12MM MAVERICK2 BALLOON| 3.0X20MM TAXUS EXPRESS2 STENT| 2.5X12MM TAXUS EXPRESS2 STENT| 2.5X24MM TAXUS EXPRESS2 STENT| CORDIS 6F 110CM 155 PIGTAIL GUIDE CATHETER| CORDIS 8F 100CM XB 3.5 GUIDE CATHETER| ENCORE INFLATION DEVICE X2| CORDIS 6F 100CM JL 4.0 GUIDE CATHETER