BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 612324 · Received June 7, 2005

    Report

    Report Number
    6000089-2005-00881
    Event Type
    Injury
    Date Received
    June 7, 2005
    Date of Event
    May 9, 2005
    Report Date
    May 10, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLINICAL STUDY, SAME CASE AS MDR 6000089-2005-00882. SAME PT AS MDR 6000089-2005-00883, AND -00884. IT WAS REPORTED THAT 31 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE THE PT EXPERIENCED AN MI AND SUBSEQUENTLY UNDERWENT A TARGET VESSEL REINTERVENTION (TVR). THE INDEX PROCEDURE TREATED TWO TARGET LESIONS. TARGET LESION 1 WAS A 2.5 MM VESSEL DIAMETER, 80% STENOSED BIFURCATED REGION OF THE 2ND DIAGONAL ARTERY. THE PHYSICIAN PERFORMED A T-STENT PROCEDURE ON THE TARGET LESION. THE LESION WAS PREDILATED PRIOR TO THE SUCCESSFUL PLACEMENT OF ONE TAXUS EXPRESS2 8.8% 2.5X12MM (LOT 7028872) DRUG ELUTING STENT. THE DRUG ELUTING STENT WAS POST DILATED AFTER DEPLOYMENT. TARGET LESION 2 WAS A 3.5 MM VESSEL DIAMETER, 50% STENOSED REGION OF THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PROCEDURE WAS PERFORMED TO ALLEVIATE IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED STENT. THE PHYSICIAN PREDIALTED THE LESION PRIOR TO PLACING ONE TAXUS EXPRESS2 8.8% 3.0X24 MM (LOT 7081509) DRUG ELUTING STENT. THE DRUG ELUTING STENT WAS POST DILATED AFTER DEPLOYMENT. IT WAS REPORTED THAT A GRADE B DISSECTION AT THE TARGET LESION WAS A PROCEDURAL COMPLICATION. THE PT WAS DISCHARGED FROM THE HOSP 6 DAYS POST INDEX PROCEDURE RECEIVING ASA, AND PLAVIX. THE SITE REPORTED THAT THE PT EXPERIENCED AN ANTERIOR/POSTERIOR/INFERIROR/LATERAL Q-WAVE MI AND THEN UNDERWENT A TVR A 31 DAYS POST INDEX PROCEDURE. THE ACTIONS LISTED TO ALLEVIATE THE MI WERE HOSPITALIZATION, REINTERVENTION, AND CARDIAC MEDICATION CHANGE. THHE TVR WAS PERFORMED TO ALLEVIATE FOCAL IN-STENT RESTENOSIS IN THE MID LAD. THE PHYSICIAN TREATED THE TARGET VESSEL BY PLACING ONE JOHNSON & JOHNSON CYPHER STENT. DURING THIS PROCEDURE THE PHYSICIAN ALSO PLACED ONE CYPHER STENT IN THE MID RIGHT CORONARY ARTERY (RCA). THE MID RCA WAS NOT A TARGET VESSEL OF THE INDEX PROCEDURE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED BY THE SITE THAT THE TVR WAS NOT RELATED TO THE TAXUS STENTS. ARRIVE 2 PROCEDURE TARGET LESION 1 WAS 10.0 MM LONG, AND TARGET LESION 2 WAS 20.0 MM LONG. TARGET LESION 1 WAS TRETED WITH BIFURCATION ANGIOPLASTY AND STENT PLACEMENT WITH SIMULTANEOUS INFLATION OF A 2.5 X 12 MM TAXUS STENT IN THE DIAGONAL AND INFLATION OF A BALLOON IN THE LAD. RESIDUAL STENOSIS WAS 0% FOLLOWING POST-DILATATION. TARGET LESION 2 WAS T-STENTED ACROSS THE DIAGONAL WITH A 3.0 X 24 MM TAXUS STENT. RESIDUAL STENOSIS WAS 0% FOLLOWING POST-DILATATION. THE PATIENT RETURNED TO THE CATH LAB THREE DAYS POST INDEX PROCEDURE FOR A PLANNED INTERVENTION TO THE PROXIMAL RCA AND WAS TREATED WITH A 3.5 X 18 MM CYPHER STENT. RESIDUAL STENOSIS WAS 0%. FIVE DAYS POST INDEX PROCEDURE THE PATIENT HAD AN ELECTROPHYSIOLOGIC STUDY AND UNDERWENT IMPLANTATION OF AN AICD AND WAS SHOCKED FOUR TIMES DURING THE INSERTION. OVERNIGHT, THE PATIENT HAD THREE EPISODES OF VT WHICH REQUIRED PACED TERMINATION. POST DISCHARGE, THE PATIENT HAD DEFIBRILLATOR FIRING FOR RECURRENT EPISODES OF VT AND RETURNED TO THE HOSPITAL FOR EVALUATION SEVEN DAYS POST INDEX PROCEDURE. EKG REVEALED A SINUS RHYTHM WITH ST-T WAVE ABNORMALITIES. ENZYMES WERE ELEVATED AND APPEARED TO MEET GUIDELINE CRITERIA FOR AN MI. THE PHYSICIAN FELT THAT THE ENZYMES WERE DUE TO ICD FIRING. FOR THIS REASON, THE SITE HAS DECIDED NOT TO REPORT THE MI AS AN EVENT. THIRTY-ONE DAYS POST ARRIVE 2 ENROLLMENT THE PATIENT WAS TAKEN TO THE ER IN ACUTE RESPIRATORY ARREST AND CHEST X-RAY CONFIRMED MODERATE CHF. THE PATIENT HAD HAD MULTIPLE EPISODES OF VENTRICULAR TACHYCARDIA AND REQUIRED EMERGENT INTUBATION. THE PATIENT WAS TAKEN DIRECTLY TO THE CARDIAC CATH LAB AND WAS ADMITTED WITH CARDIOGENIC SHOCK. CARDIAC CATHETERIZATION REVEALED THAT THE LMCA HAD DISTAL THROMBUS, THE LCX HAD MILD TO MODERATE DIFFUSE DISEASE, THE LAD HAD PROXIMAL THROMBUS, AND THROMBUS IN MID LAD STENT. THE RCA HAD THROMBUS SCATTERED THROUGHOUT ITS LENGTH. AT THE COMPLETION OF CORONARY ARTERY IMAGING THE PATIENT SHOWED A PACED RHYTHM BUT WAS WITHOUT BLOOD PRESSURE. AN INTRA-AORTIC BALLOON PUMP WAS INSERTED, CHEST COMPRESSIONS WERE GIVEN AND THE PATIENT WAS ON MULTIPLE DRIPS. IN THE OPINION OF THE PHYSICIAN THE ST WAS NOT RELATED TO THE TAXUS STENTS. THE PATIENT'S ENZYMES MET GUIDELINE CRITERIA FOR AN MI 31 DAYS POST INDEX PROCEDURE. IN THE OPINION OF THE PHYSICIAN THERE WAS AN UNKNOWN RELATIONSHIP BETWEEN THE MI, THE TAXUS STENTS, AND THE TARGET VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM DRUG COATED STENT NIQ BOSTON SCIENTIFIC TAXUS EXPRESS2 8.8% 2.50 X 12 MM 7028872

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R