BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1021123 · Received March 27, 2008

    Report

    Report Number
    2134265-2008-00891
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 PROD FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR #2134265-2008-00892. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THROMBOSIS OCCURRED. THE PT PRESENTED EMERGENTLY WITH CHEST PAIN AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. CORONARY ANGIOGRAPHY REVEALED A COMPLETE OCCLUSION IN THE MID LEFT ANTERIOR DESCENDING (LAD). ACUTE CORONARY SYNDROME WAS SUSPECTED, SO THROMBOTIC ASPIRATION WAS DONE WITH AN ASPIRATION CATHETER, REDUCING THE STENOSIS FROM 100% TO 75%. THE LESION WAS LOCATED IN THE MID TO DISTAL LAD. THE MID LAD HAD A DIAMETER OF 3MM, AND THE DISTAL LAD HAD A DIAMETER OF 2.5MM. THE PHYSICIAN IMPLANTED A 2.50X12MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE DISTAL LAD AT 12 ATMS, AND THEN IMPLANTED A 3.00X20MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE MID LAD AT 12 ATMS, OVERLAPPING THE 2.50X12MM TAXUS STENT. THE LESION WAS NOT PRE OR POST DILATED, AS PER THE PHYSICIAN'S OPINION, DIRECT STENTING WAS THE BEST OPTION FOR THIS PT'S PROGNOSIS, BECAUSE PLAIN OLD BALLOON ANGIOPLASTY (POBA) HAD POTENTIAL ISOLATION OF RESIDUAL STENOSIS. THE FINAL CORONARY ANGIOGRAM DETECTED SOME CARDIAC SPASM, BUT NO DISSECTION OR ANEURYSM FORMATION, AND BLOOD FLOW WAS RE-ESTABLISHED. POST IVUS WAS USED. THE 300MG OF CLOPIDOGREL WAS USED DURING THE PROCEDURE. FOLLOWING THE PROCEDURE, THE PT REMAINED HOSPITALIZED, TAKING ANTIPLATELET DRUGS AS PRESCRIBED (BAY ASPIRIN 100MG/DAY, CLOPIDOGREL 75MG/DAY). EIGHT DAYS POST THE ORIGINAL STENTING PROCEDURE, THE PT REPORTED CHEST PAIN. CORONARY ANGIOGRAPHY REVEALED THAT THE PROXIMAL PORTION OF THE 3.00X20MM TAXUS STENT WAS TOTALLY OCCLUDED. THROMBOTIC ASPIRATION WAS PERFORMED WITH A THROMBECTOMY CATHETER, AND POBA WAS PERFORMED WITH A 2.50X15MM NON-BSC BALLOON. HAZY SEGMENTS WERE OBSERVED VIA ANGIOGRAPHY BETWEEN THE 2.50X12MM TAXUS STENT AND THE 3.00X20MM TAXUS STENT, AND IN THE DISTAL PORTION OF THE 2.50X20MM TAXUS STENT. POBA WAS PERFORMED ON THE TWO HAZY SEGMENTS WITH A 2.50X15MM NON-BSC BALLOON. THEN, THE PHYSICIAN IMPLANTED A 2.50X8MM NON-BSC DRUG ELUTING STENT IN THE DISTAL PORTION OF THE 2.50X20MM TAXUS STENT AT 16 ATMS, OVERLAPPING THE 2.50X20MM TAXUS STENT. THEN, A 3.00X13MM NON-BSC DRUG ELUTING STENT WAS IMPLANTED BETWEEN THE 2.50X12MM TAXUS STENT AND THE 3.00X20MM TAXUS STENT AT 16 ATMS, OVERLAPPING BOTH ENDS OF THE TWO TAXUS STENTS. AT THIS TIME, THE MID TO DISTAL LAD WAS FULLY COVERED WITH THE NON-BSC AND TAXUS STENTS. FINAL ANGIOGRAPHY REVEALED OPTIMAL BLOOD FLOW. THE PT REMAINS HOSPITALIZED, AND HIS CONDITION IS NOTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 3.00X20MM

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention