BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STEN SYSTEM

    MDR report key: 610113 · Received June 1, 2005

    Report

    Report Number
    6000089-2005-00858
    Event Type
    Injury
    Date Received
    June 1, 2005
    Date of Event
    December 13, 2004
    Report Date
    May 11, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS THE SVG TO RCA, AND THE STENT WAS NOT POST DILATED AFTER DEPLOYMENT. TARGET LESION 1 WAS 10.0MM IN LENGTH, AND RESIDUAL STENOSIS WAS LESS THAN 10%. A FILTERWIRE EZ SYSTEM WAS PLACED DISTALLY IN THE GRAFT BEFORE THE DISTAL ANASTOMOSIS DURING THE PROCEDURE. MODERATE LESION WERE IDENTIFIED IN THE OSTIUM OF THE SVG TO RCA AND IN THE DISTAL ANASTOMOSIS BUT WERE NOT TREATED AT THIS TIME. FINAL ANGIOGRAPHY DEMONSTRATED NO OCCLUSIVE DISSECTION FLAPS AND NORMAL ANTEGRADE FLOW. THE PT PRESENTED TO THE PHYSICIAN'S OFFICE WITH COMPLAINTS OF EXERTIONAL CHEST PAIN, 30 DAYS POST INDEX PROCEDURE, THAT WAS RELIEVED WITH REST. CARDIAC CATHETERIZATION WAS RECOMMENDED TO EVALUATE THE PATIENT'S RECURRENT SYMPTOMS OF CHEST PAIN. ANGIOGRAPHY 33 DAYS POST INDEX PROCEDURE REVEALED THAT THE LMCA WAS PATENT, THE LAD HAD 40% PROXIMAL STENOSIS WITH MILD TO MODERATE CALCIFICATION, AND THE LCX WAS PATENT. THE RCA HAD 50-60% STENOSIS IN THE PROXIMAL SEGMENT OF THE R-PLB, 60% STENOSIS (NEXT TO A BIFURCATION) IN THE DISTAL SEGMENT OF THE R-PLB. THE SVG TO RCA HAD 75% COMPLEX SURFACE STENOSIS IN THE AORTO-OSTIUM AND PROXIMAL SEGMENT, PATENT STENT IN THE BODY OF THE SVG, AND 75% STENOSIS IN THE DISTAL ANASTOMOSIS. INTERVENTION CONSISTED OF PTCA TO THE AORTO-OSTIUM AND PROXIMAL SEGMENT, PATENT STENT IN THE BODY OF THE SVG, AND 75% STENOSIS IN THE DISTAL ANASTOMOSIS. INTERVENTION CONSISTED OF PTCA TO THE AORTO-OSTIUM OF THE SVG TO RCA (TARGET VESSEL) AND PLACEMENT OF A 4.0 X 12 MM TAXUS STENT, WITH 0% RESIDUAL STENOSIS. THE NATIVE RCA DISTAL TO THE SVG WAS TREATED WITH PTCA (NOT THE DISTAL ANASTOMOSIS THAT WAAS LISTED IN THE CTH REPORT). A STENT WAS PLACED INTO THE NATIVE DISTAL RCA EXTENDING INTO THE R-PDA. THIS "JAILED" THE OSTIUM OF THE R-PLB. A DISSECTION OCCURRED IN THE R-PLB DISTAL TO THE STENT AND EXTENDED FURTHER DOWN IN THE VESSEL, AND ADDITIONAL TAXUS STENTS WERE IMPLANTED. RESIDUAL STENOSIS WAS 0% POST-DILATION WITH EXCELLENT FLOW AND NO EVIDENCE OF INTRALUMINAL FILLING DEFECTS OR DISSECTION. IN THE OPINION OF THE PHYSICIAN THERE WAS AN UNKNOWN RELATIONSHIP BETWEEN THE TAXUS STENT AND THE EVENT.

    Description of Event or Problem · 1

    CLINICAL STUDY. IT WAS REPORTED THAT 33 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE THE PATIENT UNDERWENT A TARGET VESSEL REINTERVENTION (TVR) TO THE SAPHENOUS VEIN GRAFT (SVG) OF THE MID RIGHT CORONARY (RCA). THE INDEX PROCEDURE TREATED ONE TARGET LESION. TARGET LESION 1 WAS A 3.5 MM VESSEL DIAMETER, 80% STENOSED REGION OF THE SVG OF THE MID RCA. THE PHYSICIAN PREDILATED THE LESION PRIOR TO PLACING ONE TAXUS EXPRESS2 8.8% 3.5X16MM (LOT 6931020) DRUG ELUTING STENT WITHOUT COMPLICATION. THE DRUG ELUTING STENT WAS POST DILATED AFTER DEPLOYMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL LATER THAT DAY RECEIVING ASA, AND PLAVIX. THE SITE REPORTED THAT THE PATIET UNDERWENT A TVR TO THE SVG OF THE MID RCA 33 DAYS POST INDEX PROCEDURE. THE PHYSICIAN TREATED THE TARGET VESSEL BY PLACING ONE EXPRESS2 STENT. DURING THIS PROCEDURE THE PHYSICIAN ALSO TREATED TWO NON TARGET VESSELS PLACING THREE TAXUS STENTS IN THE 1ST RIGHT POSTERIOR LATERAL ARTERY (RPL), AND ONE TAXUS STENT IN THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ONE DAY POST TVR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STEN SYSTEM DRUG COATED STENT MAF BOSTON SCIENTIFIC TAXUS EXPRESS2 8.8% 3.50 X 16MM 6931020

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R