BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1111664 · Received August 12, 2008

    Report

    Report Number
    2134265-2008-02294
    Event Type
    Death
    Date Received
    August 12, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 16, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. THE STENT REMAINS IMPLANTED. THE COMPLAINANT INDICATED THAT THE DELIVERY DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE 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.

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2008-02291, 2134265-2008-02292, 2134265-2008-02293. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, LATE STENT THROMBOSIS AND PATIENT DEATH OCCURRED. THE PATIENT PRESENTED WITH CHEST DISCOMFORT. THE PHYSICIAN IDENTIFIED THE LESIONS TO BE TREATED LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE LEFT CIRCUMFLEX (LCX) ARTERY. THE LAD WAS HEAVILY CALCIFIED AND TORTUOUS. THE PHYSICIAN ADVANCED A .014"X300CM BMW WIRE TO THE PROXIMAL LAD. A 2.5X30MM MAVERICK BALLOON WAS ADVANCED TO THE LESION AND INFLATED AT 16 ATMS FOR 40 SECONDS. THEN, THE PHYSICIAN ADVANCED A 2.5X20MM TAXUS EXPRESS2 DRUG ELUTING STENT TO THE LESION AND DEPLOYED IT AT 18 ATMS FOR 20 SECONDS. NEXT, A 2.5X20MM MAVERICK BALLOON WAS INFLATED AT THE LESION SITE FOR 7 ATMS FOR 25 SECONDS AND 8 ATMS FOR 15 SECONDS. THE PHYSICIAN THEN PLACED A 2.75X8MM TAXUS EXPRESS2 STENT IN THE PROXIMAL LAD AND DEPLOYED IT AT 16 ATMS FOR 20 SECONDS, AND AGAIN INFLATED THE MAVERICK BALLOON AT 8 ATMS FOR 30 SECONDS. THE PHYSICIAN THEN ATTEMPTED TO PLACE A 2.5X15MM NON-BSC STENT, BUT COULD NOT CROSS THE LESION. THE NON-BSC STENT WAS REMOVED, AND A 2.75MM MAVERICK BALLOON WAS INFLATED AT 12 ATMS FOR 10 SECONDS, 12 ATMS FOR 20 SECONDS, AND 14 ATMS FOR 15 SECONDS. THE PHYSICIAN THEN ADVANCED A NON-BSC WIRE TO THE LAD. THE PHYSICIAN INFLATED A BALLOON (UNSPECIFIED TYPE/SIZE) AT 14 ATMS FOR 10 SECONDS AND THEN DELIVERED AND DEPLOYED A 3.5X8MM NON-BSC STENT AT 18 ATMS FOR 20 SECONDS. ALTOGETHER, THE LAD ACCOMMODATED, FROM ITS OSTIUM TO THE MID POSITION, THREE STENTS. NEXT, THE PHYSICIAN TREATED THE LCX. A WIRE WAS ADVANCED TO THE LESION SITE IN THE LCX, AND A 2.75X8MM TAXUS EXPRESS2 STENT WAS DELIVERED AND DEPLOYED AT 10 ATMS FOR 25 SECONDS. A BALLOON (UNSPECIFIED SIZE/TYPE) WAS THEN INFLATED AT 8 ATMS FOR 10 SECONDS, AND THEN ANOTHER 2.75X8MM TAXUS EXPRESS2 STENT WAS DEPLOYED AT 18 ATMS FOR 20 SECONDS. TIMI 3 FLOW WAS NOTED THROUGHOUT THE CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND WITHOUT COMPLICATIONS. MEDICATIONS USED DURING THE PROCEDURE INCLUDED INTEGRILIN, PLAVIX, HEPARIN AND NITROGLYCERINE. AT 799 DAYS LATER, THE PATIENT PRESENTED EMERGENTLY WITH ACUTE INFERIOR ST ELEVATION MYOCARDIAL INFARCTION, STATUS POST THROMBOLYTIC THERAPY WITH FAILURE TO REPERFUSE. THE PATIENT ARRIVED INTUBATED AND ON MULTIPLE PRESSOR AGENTS AND WITH UNRESPONSIVE. THE PATIENT WAS ON LEVOPHEOL. THE PATIENT HAD RECENTLY BEEN TAKEN OFF OF PLAVIX BY HIS GENERAL HEALTH CARE PROVIDER (THREE DAYS PRIOR TO EVENT). TESTS SHOWED THAT THERE WAS A 90% PROXIMAL LESION WITH VISIBLE THROMBUS PRESENT AND TIMI-2 FLOW IN THE LCX. THE LAD HAD 70-80% IN-STENT RESTENOSIS WITH THROMBUS PRESENT AND TIMI-2 FLOW. THE PHYSICIAN UTILIZED A GUIDE CATHETER WITH PLANS TO WIRE BOTH THE LAD AND THE LCX. DURING GUIDE CATHETER POSITIONING, THE PATIENT HAD CONTINUED AND PROGRESSIVE HYPOTENSION DESPITE INTRAVENOUS PRESSOR SUPPORT, AS WELL AS PROGRESSIVE BRADYCARDIA. A TEMPORARY PACEMAKER WAS PLACED. THE PATIENT THEN DEVELOPED RECURRENT VENTRICULAR TACHYCARDIA REQUIRING MULTIPLE CARDIOVERSIONS AND INTRAVENOUS MEDICATIONS. TESTS SHOWED TIMI 0 FLOW IN THE LAD WITH AN OSTIAL OCCLUSION AND TIMI 0 FLOW BEYOND THE PROXIMAL LCX THROMBUS. A WIRE WAS QUICKLY ADVANCED TO THE DISTAL LCX. THE PHYSICIAN ATTEMPTED TO ADVANCE A THROMBECTOMY CATHETER, BUT WAS UNABLE TO ADVANCE THIS BEYOND THE OSTIAL LCX. THEREFORE, THE PHYSICIAN ADVANCED A 3X12MM MAVERICK BALLOON TO THE LCX AND DILATED THE LCX PROXIMALLY AND OSTIALLY, AS WELL AS THE DISTAL LEFT MAIN TO 8 ATMS. THE PATIENT WAS CONTINUED TO BE SUPPORTED WITH INTERMITTENT CPR AND VASOPRESSORS. FLOW WAS REESTABLISHED IN THE LCX BUT NO RUNOFF WAS PRESENT. THE PATIENT CONTINUED TO HAVE AN OSTIAL LAD OCCLUSION. GIVEN THE DURATION OF HYPOTENSION AND INABILITY TO RESTORE CORONARY FLOW, THE PROCEDURE WAS TERMINATED AND CODE EFFORTS WERE ALSO TERMINATED. THE TIME OF DEATH WAS CALLED AND THE CAUSE OF DEATH WAS DETERMINED TO BE ACUTE MYOCARDIAL INFARCTION WITH SIGNIFICANT THROMBUS IN THE LEFT MAIN, LAD, AND LCX. FURTHER INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 2.75X8MM

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death 3.5X8MM MINI VISION STENT| CORDIS 6FR JLSH 3.5XM CATHETER| 2.5X16MM MINI VISION STENT| .015X300CM HI TORQUE WIGGLE WIRE