BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1933480 · Received December 20, 2010

    Report

    Report Number
    2134265-2010-05609
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    January 17, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MFR REPORT #: 2134265-2010-05605, 2134265-2010-05606, 2134265-2010-05608. IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, AN ACUTE MYOCARDIAL INFARCTION OCCURRED. THE INDEX PROCEDURE PLACED 3 UNSPECIFIED TAXUS EXPRESS2 STENTS IN THE PROXIMAL RIGHT CORONARY ARTERY AND 1 UNSPECIFIED TAXUS EXPRESS2 STENT IN THE DISTAL CIRCUMFLEX ARTERY. IN (B)(6) 2010, THE PATIENT EXPERIENCED AN ACUTE MYOCARDIAL INFARCTION (INFERIOR WALL). A TARGET LESION REVASCULARIZATION WAS PERFORMED. PER THE PHYSICIAN, THE MYOCARDIAL INFARCTION WAS LISTED AS "DEFINITELY RELATED" TO THE STUDY STENTS AND POSSIBLY RELATED TO THE ANTIPLATELETS. IN (B)(6) 2010, THE PATIENT DEVELOPED CHOLEDOCHOLITHIASIS ANGIOCHOLITIS AND DIED. PER THE PHYSICIAN, THE DEATH EVENT WAS LISTED AS "UNRELATED" TO THE STUDY STENTS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH THREE TAXUS EXPRESS2 STENTS (2.75X28MM, 3.0X32MM, 3.5X12MM) AFTER PRE-DILATION. POST-IVUS WAS PERFORMED CONFIRMING THE STENTS WERE EXPANDED WELL WITH 0% RESIDUAL STENOSIS. THE DISTAL CIRCUMFLEX ARTERY WAS TREATED WITH A 3.0X28MM TAXUS EXPRESS2 STENT AFTER PRE-DILATION. POST-IVUS WAS PERFORMED CONFIRMING THE STENT WAS EXPANDED WELL RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT HAD NO ANGINAL SYMPTOMS AT THE 1 MONTH, 6 MONTH, 9 MONTH AND 1 YEAR FOLLOW UP VISITS. AT THE TIME OF MYOCARDIAL INFARCTION, THE TARGET LESION REVASCULARIZATION WAS PERFORMED IN THE 100% STENOSED, 3.0MM IN DIAMETER LESION LOCATED IN THE MID RCA. TREATMENT UTILIZED BALLOON ANGIOPLASTY RESULTING IN 25% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED 11 DAYS LATER IN IMPROVED CONDITION. IN 02/2010, ENDOSCOPIC INSPECTION AND TREATMENT WERE PERFORMED FOR THE CHOLEDOCHOLITHIASIS ANGIOCHOLITIS. THE PATIENT DEVELOPED BLOOD POISONING AND DIED DUE TO MULTI ORGAN FAILURE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE INDEX PROCEDURE TREATED THE DE NOVO, 100% STENOSED 3.3X16MM TARGET LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE 3 STENTS PLACED IN THE PROXIMAL RCA WERE OVERLAPPING. NO POST DILATION WAS PERFORMED. THE LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) ARTERY WAS A DE NOVO, 90% STENOSED 3.3X5.2MM TARGET LESION. POST DILATION WAS NOT PERFORMED. THE PATIENT WAS DISCHARGED WITHOUT COMPLICATION THE NEXT DAY ON BAYASPIRIN AND PANALDINE. PER THE PHYSICIAN, THE ACUTE MI EVENT WAS LISTED AS "DEFINITELY RELATED" TO THE STUDY STENT.

    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 - GALWAY H7493897032300 11177527

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R 3.5X12 TAXUS EXPRESS2 STENTTAXUS EXPRESS 2 STENT| 3.0X28 TAXUS EXPRESS2 STENT| 2.75X28 TAXUS EXPRESS2 STENT