BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1842551 · Received September 23, 2010

    Report

    Report Number
    2134265-2010-04267
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT.(B)(4).DEVICE EVALUATED BY MANUFACTURER - AS A UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS CANNOT BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION 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 REPORT#: 2134265-2010-04268 AND 2134265-2010-04269. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED EMERGENTLY WITH CHEST PAIN AND AN ACUTE MYOCARDIAL INFARCTION WITH ST ELEVATIONS. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 80% STENOSED LONG LESION COVERING ALMOST THE ENTIRE VESSEL WAS LOCATED IN A SEVERELY CALCIFIED AND SEVERELY TORTUOUS MID RIGHT CORONARY ARTERY (RCA) THAT CONTAINED A BEND OF GREATER THAN 90 DEGREES, WAS OCCLUDED WITH THROMBUS AND HAD TIMI FLOW OF I. THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH A FORTE GUIDE WIRE, BUT COULD NOT CROSS. AFTER THE EXCHANGE OF MULTIPLE UNKNOWN GUIDE CATHETERS, THE FORTE GUIDE WIRE WAS ABLE TO CROSS THE LESION. A PT GRAPHIX GUIDE WIRE WAS THEN ADVANCED TO THE LESION AS A BUDDY WIRE. A 3.0X15MM MAVERICK2 BALLOON WAS ADVANCED TO THE LESION AND INFLATED, CAUSING A SPIRAL DISSECTION. A 2.5X12MM MAVERICK2 BALLOON AND A 2.75X12MM PROMUS STENT WERE USED TO TREAT THE DISSECTION. ANOTHER 2.75X12MM PROMUS STENT WAS ADVANCED TO TREAT THE REST OF THE LESION BUT COULD NOT CROSS THE LESION. A 3.0X12MM TAXUS LIBERTE' STENT WAS ADVANCED TO THE LESION, BUT COULD NOT CROSS AFTER MULTIPLE ATTEMPTS. WHILE REMOVING THE DEVICE, THE STENT DISLODGED IN THE PROXIMAL RCA JUST AFTER THE GUIDE CATHETER APPROXIMATELY 5MM AFTER THE OSTIUM IN THE PROXIMAL RCA. THE THIRD WIRE LOST POSITION AND ALL WIRES AND THE GUIDE CATHETER WAS REMOVED. A NEW FORTE WIRE WAS ADVANCED. A 1.5X15MM MAVERICK2 BALLOON WAS ADVANCED TO THE DISLODGED STENT AND INFLATED TO 15 ATMS FOR 30 SECONDS TO DEPLOY THE DISLODGED STENT. A 3.0X12MM QUANTUM MAVERICK BALLOON WAS ADVANCED AND USED TO POST-DILATE THE STENT. THE TAXUS LIBERTE' STENT WAS CONFIRMED TO BE WELL APPOSED VIA ANGIO WITH NO EVIDENCE OF VESSEL DISSECTION. DUE TO THE LENGTH OF THE LESION, THE FORTE GUIDE WIRE WAS ADVANCED FURTHER INTO THE RCA TO BEGIN TREATING THE REST OF THE LESION. THE ADVANCEMENT OF THE FORTE GUIDE WIRE CAUSED A DISSECTION IN THE DISTAL RCA. THE PROCEDURE WAS COMPLETED AT THIS TIME AND AN INTRAVENOUS PACEMAKER WAS PLACED. THE PATIENT WAS CHEST PAIN FREE WITH NORMALIZED ELECTRICAL PARAMETERS AND TIMI , IIB FLOW. THE PATIENT WAS STABLE AND TRANSFERRED TO ANOTHER FACILITY FOR A BYPASS GRAFTING PROCEDURE TO BYPASS THE RCA THAT WAS PERFORMED THE NEXT DAY. EXCELLENT RESULTS WERE REPORTED POST SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS LISTED AS 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 - MAPLE GROVE H7493893612300 13073499

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention 2.5X12MM MAVERICK2 BALLOON| PT GRAPHIX GUIDE WIRE| (2) 2.75X12MM PROMUS STENTS| 3.0X15MM MAVERICK2 BALLOON| FORTE GUIDE WIRE