BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3103047 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-02927
    Event Type
    Death
    Date Received
    May 9, 2013
    Date of Event
    January 18, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: 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).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS MDR# 2134265-2013-02924, 2134265-2013-02925, AND 2134265-2013-02926. SAME PATIENT AS MDR#2134265-2013-02928, 2134265-2013-02932, 2134265-2013-03375, 2134265-2013-03378 AND 2134265-2013-03379. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE THE PATIENT DIED. IN (B)(6) 2008, THE PATIENT WAS DIAGNOSED WITH SILENT ISCHEMIA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 90% STENOSED, 28 X 4.00MM TARGET LESION WAS LOCATED IN MID RIGHT CORONARY ARTERY (RCA). THE TARGET LESION WAS PRE-DILATED USING TWO QUANTUM MAVERICK BALLOONS, A 3.00 X 16MM BALLOON, AND A 2.5 X 20 MM BALLOON. DURING ANGIOPLASTY THE 2.5 X 20MM BALLOON RUPTURED, FOLLOWING WHICH THERE WAS EVIDENCE OF A SMALL TRANSIENT EMBOLUS RESULTING IN 'ST ELEVATION' AND 'NON SUSTAINED VENTRICULAR TACHYCARDIA.' THIS WAS TREATED WITH INTRACORONARY NITROGLYCERINE AND AMIODARONE. PER CORE LAB A GRADE "C" DISSECTION WAS ALSO NOTED WHICH WAS TREATED WITH PLACEMENT OF A 4.00 X 28 MM STUDY STENT. POST STENT DEPLOYMENT, AFTER ADMINISTRATION OF INTRA NITROGLYCERINE, THERE WAS EVIDENCE OF A 'LESION UPSTREAM' WHICH HAD PROGRESSED ANGIOGRAPHICALLY EITHER DUE TO THE WIRE, GUIDE OR 'BALLOON TRAUMA.' PER CORE LAB FOLLOWING STENT PLACEMENT A GRADE "B" DISSECTION WAS NOTED. THIS WAS TREATED WITH PLACEMENT OF SECOND 4.0 X 16 MM TAXUS ION STENT OVERLAPPING THE FIRST STUDY STENT. FOLLOWING POST DILATATION, THERE WAS EXCELLENT ANGIOGRAPHIC RESULT WITH SMOOTH FLOW NOTED. RESIDUAL STENOSIS WAS 0%. IN ADDITION, A NON TARGET LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS TREATED. AFTER AN UNSUCCESSFUL PRE-DILATATION ATTEMPT USING A 2.5 X 20MM BSC BALLOON, THE LESION WAS DILATED USING A 3.5 X 12MM QUANTUM MAVERICK BALLOON WITH GOOD ANGIOGRAPHIC RESULTS. A 3.5 X 28MM TAXUS STENT WAS THEN DEPLOYED. 'SLIGHT SLIPPAGE' OF THE STENT WAS NOTED DISTALLY LEAVING THE PROXIMAL END OF THE LESION UNSTENTED. A 3.5 X 8MM TAXUS STENT WAS DEPLOYED OVERLAPPING THE PREVIOUS STENT TO COVER THE LESION. FOLLOWING STENT DEPLOYMENT THE DISTAL DIAGONAL BRANCH HAD RECURRENT OSTIAL NARROWING WHICH WAS TREATEMED WITH A 2.5MM MAVERICK BALLOON RESULTING IN GOOD FLOW. IN ADDITION, THERE WAS OSTIAL POST STENT NARROWING WITH RELATIVELY "SLOW-FLOW" NOTED IN THE SEPTAL PERFORATOR. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL. IN JANUARY 2013, THE PATIENT DIED DUE TO END STAGE CARDIAC DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203368 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death