BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1900709 · Received November 16, 2010

    Report

    Report Number
    2134265-2010-05167
    Event Type
    Death
    Date Received
    November 16, 2010
    Date of Event
    January 2, 2010
    Report Date
    October 20, 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

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND AND MET ALL SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT FOLLOWING DIALYSIS IN ANOTHER DEPARTMENT OF THE SITE, THE PATIENT WAS DISCHARGED 11 DAYS POST THE INDEX PROCEDURE. STENT THROMBOSIS WAS REPORTED PER INDEPENDENT MEDICAL REVIEW (IMR) ADJUDICATION.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT DIED. THE INDEX PROCEDURE TREATED THE DE NOVO, TYPE B2, 64% STENOSED MINIMUM LUMEN DIAMETER 1.22MM X 9.9MM LENGTH TARGET LESION LOCATED IN THE SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. TREATMENT PLACED A 3.0X16MM TAXUS EXPRESS2 DRUG ELUTING STUDY STENT DEPLOYED AT 20 ATM'S. POST DILATION WAS PERFORMED WITH A 9MM LENGTH BALLOON INFLATED TO 16 ATM'S. IVUS WAS PERFORMED CONFIRMING THE STENT WAS WELL APPOSED WITH A FINAL VESSEL LUMEN DIAMETER OF 2.95MM AND 0% RESIDUAL STENOSIS. A NON-TARGET LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY WAS TREATED WITH A NON BSC STENT. THE PATIENT'S ANTIPLATELET REGIMEN WAS BAYASPIRIN, PANALDINE AND PLETAAL STARTED 2 MONTHS PRIOR TO THE INDEX PROCEDURE. NO ANGINA WAS CONFIRMED AT THE 1, 6, 9 & 12 MONTH STUDY FOLLOW UP VISITS, BUT THE PATIENT HAD AN ULCERATION IN THE LEFT LOWER THIGH. ALSO, NECROSIS WAS CONFIRMED. THERE WAS A POSSIBILITY OF THREE-BRANCH STENOSIS OR OCCLUSION OF THE LOWER EXTREMITIES THE PHYSICIAN RECOMMENDED THE PATIENT FOR CATHETERIZATION, BUT THE PATIENT REFUSED. THE PATIENT WAS SCHEDULED TO GO TO THE HOSPITAL FOR DIALYTIC THERAPY (B)(6) 2010, BUT DID NOT GO TO THE HOSPITAL. A PRIMARY DOCTOR FOR DIALYSIS AND A NURSE VISITED THE PATIENT AND FOUND THE PATIENT IN A STATE OF "CADAVER STIFFENING". THE CAUSE OF DEATH WAS UNKNOWN. PER THE PHYSICIAN, THE STUDY STENT RELATION TO THE DEATH WAS LISTED AS "UNKNOWN".

    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 H7493897016300 9755060

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death CYPHER STENT