BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1021102 · Received March 27, 2008

    Report

    Report Number
    2134265-2008-00875
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    December 19, 2007
    Report Date
    February 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE WOULD 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 A ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL TRIAL. SAME CASE AS MFR # 2134265-2008-00874, - 00873. IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PT HAD A TARGET VESSEL REVASCULARIZATION. THE INDEX PROCEDURE TREATED 2 TARGET LESIONS. TARGET LESION 1 WAS IDENTIFIED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS, 28 MM LENGTH AND A 3.2MM DIAMETER. THE LESION WAS PREDILATED PRIOR TO PLACEMENT OF TWO OVERLAPPING 3.0X20MM TAXUS EXPRESS2 STENTS. RESIDUAL STENOSIS WAS 0%. TARGET LESION 2 WAS IDENTIFIED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 75% STENOSIS, 28 MM LENGTH AND A 3.0MM DIAMETER. TARGET LESION 2 WAS PREDILATED PRIOR TO PLACEMENT OF A 3.0 X 12MM TAXUS EXPRESS2 STENT. RESIDUAL STENOSIS WAS 0%. OF NOTE, THE PROXIMAL CIRCUMFLEX (CX) WAS TREATED WITH ROTATIONAL ATHERECTOMY WITH 0% RESIDUAL STENOSIS. THE PT WAS DISCHARGED ONE DAY LATER ON ASPIRIN AND PLAVIX. AT 830 DAYS POST INDEX PROCEDURE, THE PT WAS SEEN IN THE ER WITH COMPLAINTS OF SEVERE CHEST PAIN WITH NAUSEA. THE NEXT DAY, THE PT WAS ADMITTED WITH UNSTABLE ANGINA AND DIAGNOSED WITH A NON Q-WAVE MI. CARDIAC ENZYMES DID NOT MEET GUIDELINE CRITERIA FOR A MI. THE PT WAS TAKEN TO THE CATH LAB. TREATMENT THAT DAY CONSISTED OF CUTTING BALLOON ANGIOPLASTY AND PLACEMENT OF ANOTHER MFR'S 3.5 X 18MM STENT IN THE MID RCA. THERE WAS 0% RESIDUAL STENOSIS. THE PT WAS DISCHARGED THE NEXT DAY ON CONTINUED ASPIRIN AND PLAVIX. IN THE OPINION OF THE PHYSICIAN, THERE WAS NO RELATIONSHIP BETWEEN THE MI/TVR AND THE TAXUS STENTS. IN 2008, THE CEC DETERMINED A POSSIBLE RELATIONSHIP BETWEEN THE MI/TVR AND THE TAXUS STENTS.

    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 3.0 X 12 MM 7784031

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R