BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 740270 · Received July 21, 2006

    Report

    Report Number
    6000093-2006-01345
    Event Type
    Injury
    Date Received
    July 21, 2006
    Date of Event
    February 18, 2006
    Report Date
    June 23, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PT, THEREFORE NO ANALYSIS COULD BE PERFORMED. THE MFG RECORDS FOR TOP ASSEMBLY BATCH 8113159 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THERE ARE NO SIMILAR COMPLAINTS OF THIS NATURE RELATED TO THIS BATCH NUMBER. THE CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    SAME CASE AS MDR # 6000093-2006-01346. FACILITY MEDWATCH # AND PT IDENTIFIER UNIDENTIFIABLE, BLACKED OUT. IT WAS REPORTED VIA A FACILITY MEDWATCH FORM THAT THERE WAS TOTAL OCCLUSION OF THE CORONARY ARTERY. I SPOKE TO THE REPORTER OF THE FACILITY MEDWATCH AND RECEIVED THIS INFO. I CONFIRMED THE DATES OF THE INITIAL PROCEDURE AND THE INTERVENTION WITH THE FACILITY MEDWATCH REPORTER. IN THE INITIAL PROCEDURE TWO 2.5X16MM TAXUS EXPRESS2 STENTS WERE IMPLANTED IN THE LAD. THERE WERE NO COMPLICATIONS DURING THIS PROCEDURE. THE PT WAS DISCHARGED ON THE MEDICATIONS: TOPROL PLAVIX, ZOCOR, ALTASE, ASPIRIN, AND NITROGLYCERIN. FOUR DAYS LATER THE PT ENTERED THE HOSP WITH CHEST PAIN AND THE PT WAS SENT FOR AN EMERGENT PTCA PROCEDURE. CORONARY ANGIOGRAPHY REVEALED TOTAL OCCLUSION OF THE LAD. MULTIPLE ATTEMPTS TO PASS THROUGH AND OPEN THE OCCLUSION USING GUIDEWIRES WERE UNSUCCESSFUL. AT THAT POINT THE PROCEDURE WAS ABORTED; THE PT WAS STABLE AND NO LONGER HAVING CHEST PAIN. A SURGERY CONSULT WAS DONE, HOWEVER, THE PT WAS DEEMED NOT A VIABLE OPERATIVE CANDIDATE AND IT WAS DECIDED TO TREAT THE PT MEDICALLY. THE PT WAS DISCHARGED ON THE MEDICATIONS: TOPROL (INCREASED DOSE), INSULIN, ASPIRIN, ALTASE, PLAVIX, AND ZOCOR. THE PHYSICIAN FELT THE THROMBOSIS WAS RELATED TO THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 2.5X16MM 8113159

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention