BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 6043736 · Received October 20, 2016

    Report

    Report Number
    2134265-2016-09267
    Event Type
    Death
    Date Received
    October 20, 2016
    Date of Event
    June 22, 2006
    Report Date
    July 6, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. 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

    SAME CASE AS MDR ID: 2134265-2016-09270. IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT ARRIVED AT THE HOSPITAL DUE TO THE STATE OF HIS HEALTH AND IMMEDIATELY UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI). A 4.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED. UPON IMPLANTATION OF THE TAXUS EXPRESS2 STENT A NO-REFLOW INCIDENT OCCURRED AND A SECOND 2.5X15MM UNSPECIFIED STENT WAS IMPLANTED. FOUR DAYS LATER A NEW PCI PROCEDURE WAS CONDUCTED AND A 3.0X16MM TAXUS LIBERTE DRUG ELUTING STENT WAS DEPLOYED. DURING THIS PROCEDURE THE VESSEL WAS RUPTURED IN THE MEDIAL D2 (DIAGONAL) BRANCH. LATER THE SAME DAY THE PATIENT'S TEMPERATURE ROSE TO 39 CELSIUS. THE PATIENT WAS TREATED WITH ZINACEF AND PARACETAMOL. ELEVEN DAYS LATER THE PATIENT SUFFERED A HEART ATTACK WITH CARDIOGENIC SHOCK. CORONARY ANGIOGRAPHY WAS PERFORMED TO EXCLUDE STENT THROMBOSIS, BUT LATER THE SAME DAY THE PATIENT DIED. THE CAUSE OF DEATH WAS DOCUMENTED AS HEART ATTACK WITH CARDIOGENIC SHOCK AND STOP OF BLOOD CIRCULATION DUE TO PEA (PULSELESS ELECTRICAL ACTIVITY). POST MORTEM ANALYSIS DISCLOSED SOME TISSUE CHANGES IN THE STENTED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694526 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493800124450 7245503

    Patients

    Seq Age Sex Outcome Treatment
    1 Death