BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021280 · Received March 25, 2008

    Report

    Report Number
    9616099-2008-00788
    Event Type
    Injury
    Date Received
    March 25, 2008
    Date of Event
    August 27, 2007
    Report Date
    February 28, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FINAL RESIDUAL WAS 0% THROUGHOUT THE STENTED AREA. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS. THE PATIENT WAS DISCHARGED TWO DAYS LATER WITH ORDERS FOR DAILY ADMINISTRATION OF ASPIRIN, PLAVIX, STATINS, ACE INHIBITORS, AND BETA-BLOCKERS. AT ONE-MONTH AND SIX-MONTH FOLLOW-UPS, THE PATIENT WAS ASYMPTOMATIC AND WAS COMPLIANT WITH ALL CARDIAC MEDICATIONS. TEN MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH CHEST PAIN AND WAS ADMITTED FOR EVALUATION. ANGIOGRAPHY REVEALED THE FOLLOWING: THE 2.5 X 33 MM CYPHER SELECT IMPLANTED IN THE PROXIMAL LAD WAS PATENT WITH 0% INSTENT RESTENOSIS/PERI-STENT RESTENOSIS AND NO EVIDENCE OF CORONARY ANEURYSM. THE 2.5 X 18MM AND THE 2.5 X 13MM CYPHER SELECT STENTS IMPLANTED IN THE FIRST DIAGONAL BRANCH WERE PATENT WITH 0% INSTENT RESTENOSIS/PERI-STENT RESTENOSIS AND NO EVIDENCE OF CORONARY ANEURYSM. THE 2.25 X 18MM STENT IMPLANTED IN THE MID-LAD SHOWED A 90% FOCAL INSTENT RESTENOSIS. THE MID-LAD RESTENOSIS WAS TREATED WITH THE PLACEMENT OF AN ADDITIONAL CYPHER STENT (2.5 X 23MM). THIS EVENT RESOLVED WITHOUT SEQUELAE. CYPHER SELECT PRODUCT IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS MALE PATIENT WITH A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, SMOKING, AND DIABETES (ORALLY CONTROLLED) WAS ADMITTED FOR CORONARY EVALUATION. THE PATIENT WAS CURRENTLY TAKING ASPIRIN ONLY. THE MAIN INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA. BASELINE EVALUATION REVEALED MILD CARDIOMYOPATHY (EJECTION FRACTION OF 30-50%). ANGIOGRAPHY REVEALED SIGNIFICANT CORONARY DISEASE EXTENDING FROM THE PROXIMAL THROUGH THE MID LAD (32 MM) AND DOWN THE FIRST DIAGONAL BRANCH (18MM). THE LESION WAS DESCRIBED AS BIFURCATING AND WAS SMOOTH AND ECCENTRIC WITH LITTLE TO NO CALCIFICATION. THE VESSELS WERE NOT TORTUOUS AND THERE WAS BETWEEN 45 AND 90 DEGREES OF ANGULATION AT THE TAKE-OFF OF THE DIAGONAL BRANCH. REFERENCE VESSEL RANGED FROM 2.5MM IN THE PROXIMAL PORTIONS OF THE LAD AND IN THE DIAGONAL TO 2.25MM IN THE MID-LAD. HEPARIN AND AGGRASTAT WERE ADMINISTERED. THE 80% STENOSIS IN THE PROXIMAL LAD WAS PREDILATED WITH A 2.0 X 20MM BALLOON INFLATED TO 8 ATMS. A 2.5 X 33MM CYPHER SELECT STENT WAS DEPLOYED TO 14 ATMS. THE RESULTS WERE CONSIDERED SUB-OPTIMAL. DUE TO THE BIFURCATION, THE STENT WAS POST DILATED WITH A 3.0 X 12MM BALLOON INFLATED 10 ATMS. THEN THE 75% STENOSIS IN THE FIRST DIAGONAL BRANCH WAS PRE-DILATED WITH A 2.5 X 20MM BALLOON INFLATED TO 8 ATMS. A 2.5 X 18MM CYPHER SELECT STENT WAS DEPLOYED VIA CRUSH TECHNIQUE TO 14 ATMS WITH SUBOPTIMAL RESULTS. THE STENT WAS POST DILATED WITH A 2.0 X 20MM BALLOON INFLATED TO 12 ATMS. AN ADDITIONAL 2.5 X 13MM CYPHER SELECT STENT WAS PLACED IN THE DIAGONAL BRANCH, DISTAL TO THE FIRST, AND WAS DEPLOYED TO 14 ATMS WITH SATISFACTORY RESULTS. FINALLY, A 2.25 X 18MM CYPHER SELECT STENT WAS PLACED IN THE MID LAD AND WAS DEPLOYED TO 14 ATMS WITH SUBOPTIMAL RESULTS. TO ENSURE FULL EXPANSION, THE STENT WAS POST DILATED WITH A 3.0 X 12MM BALLOON INFLATED TO 10 ATMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT - NIQ NIQ CORDIS DE MEXICO NA I0806129

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R ACE INHIBITORS| PLAVIX| ASPIRIN| BETA-BLOCKERS| STATINS