BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-DLUTING CORONARY STENT SYTSTEM

    MDR report key: 621900 · Received July 18, 2005

    Report

    Report Number
    6000093-2005-00820
    Event Type
    Injury
    Date Received
    July 18, 2005
    Date of Event
    June 14, 2005
    Report Date
    June 20, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS MDR 6000093-2005-816, 000817, AND -00818 AND 819. SAME PATIENT AS MDR MDR 6000093-2005-00049, 00050 AND 0051 ,00052 AND 00053. IT WAS REPORTED THAT 183 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A NON Q-WAVE MYOCARDIAL INFARCTION (MI). THE INDEX PROCEDURE TREATED ONE TARGET LESION. TARGET LESION 1 WAS A 2.25MM VESSEL DIAMETER, 95% STENOSED REGION OF THE MID RIGHT CORONARY ARTERY (RCA). THE TARGET LESION HAD MODERATE CALCIFICATION AND WAS MILDLY TORTUOUS. THE PHYSICIAN PREDILATED THE LESION PRIOR TO PLACING FIVE OVERLAPPING TAXUS EXPRESS2 8.8% DRUG ELUTING STENTS (DES) WITHOUT COMPLICATION. THE FIRST DES PLACED WAS A TAXUS EXPRESS2 8.8% 2.5X24MM. A SECOND TAXUS EXPRESS2 8.8%2.5X24MM) WAS PLACED OVERLAPING 2.0MM WITH THE FIRST DES. THIS WAS FOLLOWED BY THE PLACEMENT OF TWO TAXUS EXPRESS2 8.8% 2.5X20MM. DRUG ELUTING STENTS THAT OVERLAPPED BY 1.0MM WITH EACH OTHER AND WITH THE SECOND DES. THE FINAL STENT PLACED WAS A TAXUS EXPRESS2 8.8% 2.5X12MM DRUG ELUTING STENT. THIS DRUG ELUTING STENT OVERLAPPED BY 3.0MM WITH THE STENT MOST PROXIMAL TO IT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOUR DAYS POST INDEX PROCEDURE RECEIVING ASA AND PLAVIX. THE SITE REPORTED THAT THE PATIENT EXPERIENCED A NON Q-WAVE MI 183 DAYS POST INDEX PROCEDURE. THE MI WAS RESOLVED TWO DAYS LATER. THE ACTIONS TAKEN TO RESOLVE THE MI INCLUDED HOSPITALIZATION, AND CARDIAC MEDICATION CHANGE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOUR DAYS AFTER MI RESOLUTION. IN THE OPINION OF THE PHYSICIAN THERE IS AN UNKNOWN RELATIONSHIP TO THE TAXUS STENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 60.0 MM IN LENGTH. THE INITIAL ATTEMPT AT TREATMENT WITH PREDILATATION AND A 2.5X24MM TAXUS STENT FAILED WHEN THE STENT WAS UNABLE TO BE PASSED. SUBSEQUENT PREDILATATION OF THE CALCIFIED VESSEL RESULTED IN A LARGE INTIMAL TEAR "THROUGHOUT THE ENTIRE RCA," WITH TIMI GRADE 1 DISTAL FLOW. PER CATHETERIZATION REPORT, THERE WAS ALSO A GUIDEWIRE-INDUCED INTIMAL DISSECTION AT THE BEGINNING OF THE PROCEDURE. FINAL ANGIOGRAPHY DEMONSTRATED NO RESIDUAL STENOSIS, AND NO EVIDENCE OF DISSECTION, THROMBUS, OR DISTAL EMBOLIZATION. POST INDEX PROCEDURE, THE PATIENT DEVELOPED AN ACUTE STENT THROMBOSIS WITH TOAL OCCLUSION OF THE MID RCA STENTS AND STENTING OF GAP STENOSIS BETWEEN TWO PREVIOUSLY PLACE MID RCA STENTS AND STENTING OF A DISTAL EDGE DISSECTION. THE PATIENT WAS ADMITTED WITH A 1-WEEK HISTORY OF CHEST PAIN ASSOCIATED WITH PAROXYSMAL NOCTURNAL DYSPNEA AND ORTHOPNEA 183 DAYS POST INDEX PROCEDURE. ECG SHOWED ISCHEMIC ST SEGMENT CHANGES ACROSS THE ANTERIOR PRECORDIAL LEADS. PER HISTORY AND PHYSICAL EXAM REPORT, THERE WAS ALSO EVIDENCE OF PULMONARY EDEMA ON THE ADMISSION CHEST X-RAY. CARDIAC ENZYMES WERE ELEVATED CONSISTENT WITH GUIDELINE DEFINITION OF MYOCARDIAL INFARCTION. IN THE OPINION OF THE PHYSICIAN THERE WAS AN UNKNOWN RELATIONSHIP BETWEEN THE TARGET VESSEL AND THE MI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-DLUTING CORONARY STENT SYTSTEM DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. TAXUS EXPRESS2 PACLITAXEL ELUTING CORONARY STENT 7026841

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O