BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3103054 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03378
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 25, 2008
    Report Date
    April 26, 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. (B)(4). 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) CLINICAL STUDY. SAME PATIENT AS MDR#2134265-2013-02924, 2134265-2013-02925, 2134265-2013-02926 AND 2134265-2013-02927. SAME CASE AS MDR#2134265-2013-02928, 2134265-2013-03375, 2134265-2013-02932 AND 2134265-2013-03379. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT MOVED DURING DEPLOYMENT AND VESSEL NARROWING AND SLOW-FLOW OCCURRED. 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 X16MM 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 TREATED 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203781 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention