BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1201543 · Received October 17, 2008

    Report

    Report Number
    9616099-2008-02468
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    February 7, 2008
    Report Date
    September 22, 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 PRODUCT(S) ARE NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING ROUTE SHEETS FOR THE INVOLVED LOT(S) CONFIRMED THAT THE DEVICE(S) MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. IN-STENT RESTENOSIS IS A KNOWN POTENTIAL OUTCOME OF CORONARY STENTING AND IS MULTI-FACTORIAL IN ETIOLOGY. SUBSEQUENT STENT BLOCKAGE MAY REQUIRE REPEAT DILATION OF THE STENTED AREA. WELL-KNOWN PREDICTORS ASSOCIATED WITH A HIGHER RATE OF RESTENOSIS FOLLOWING STENT IMPLANTATION INCLUDE PATIENT FACTORS SUCH AS SEX, PRIOR HISTORY OF RESTENOSIS, DIABETES, HYPERLIPIDEMIA, HYPERTENSION, UNSTABLE ANGINA, VASOSPASTIC ANGINA, RENAL DISEASE AND SMOKING; PROCEDURAL FACTORS SUCH AS DEVICE-TO-ARTERY RATIO, PRESENCE OF SIGNIFICANT RESIDUAL GRADIENT, SIGNIFICANT RESIDUAL STENOSIS, AND THE EXTENT OF DISSECTION; AND ANGIOGRAPHIC FACTORS SUCH AS THE SIZE OF THE REFERENCE VESSEL, SEVERITY OF THE STENOSIS, PRESENCE OF CALCIUM, ECCENTRIC LESIONS, SAPHENOUS VEIN GRAFT LOCATION, OSTIAL OR PROXIMAL LESION LOCATION, AND LEFT ANTERIOR DESCENDING LESION LOCATION, AS WELL AS CHRONIC TOTAL OCCLUSION AND LONG LESIONS. IN THIS CASE, THE PATIENT HAS A HISTORY OF HYPERTENSION, HIGH CHOLESTEROL, AND SMOKING AND HE PRESENTED WITH SEVERE, TRIPLE-VESSEL DISEASE. TREATMENT INCLUDED THE PLACEMENT OF FOUR STENTS IN FOUR VESSELS, THREE OF WHICH WERE SMALL CALIBER (2.5MM). THESE FACTORS INCREASE THE PATIENT'S RISK FOR RESTENOSIS. FOUR YEARS HAD PASSED SINCE THE STENTS WERE PLACED AND SIGNIFICANT PROGRESSION OF DISEASE WAS NOTED. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT IS RELATED TO A MANUFACTURING ISSUE OR DEVICE DEFECT. THERE ARE PATIENT, AND VESSEL/LESION FACTORS THAT LIKELY CONTRIBUTED TO THIS REPORTED EVENT OF PERI-STENT RESTENOSIS. EUROPEAN DISTRIBUTED CYPHER PRODUCT IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT.

    Description of Event or Problem · 1

    THIS MALE PATIENT WITH A HISTORY OF HYPERTENSION, HIGH CHOLESTEROL, SMOKING AND AN EJECTION FRACTION OF 58% WAS ADMITTED FOR CORONARY ANGIOGRAPHIC EVALUATION. HE WAS CURRENTLY TAKING LONG ACTING NITRATES, BETA-BLOCKER THERAPY, ASPIRIN, TICLOPIDINE, LIPID LOWERING AGENTS, AND SIMVASTATINE. ANGIOGRAPHY REVEALED THREE LESIONS, ONE IN THE BIFURCATION OF THE RIGHT POSTERIOR DESCENDING ARTERY (PDA)/ POSTEROLATERAL BRANCH (RPL), ONE IN THE MID-LAD, AND ONE IN THE OBTUSE MARGINAL BRANCH (OM). THE LESIONS WERE TREATED WITH PLACEMENT OF FOUR CYPHER STENTS: A 2.5 X 28MM IN THE PDA, A 3.0 X 18MM IN THE RPL, A 2.5 X 18MM IN THE MID-LAD AND A 2.5 X 18MM IN THE OM. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION. APPROXIMATELY FOUR YEARS AND SEVEN MONTHS POST INDEX PROCEDURE, THE PATIENT WAS HOSPITALIZED DUE TO CHEST PAIN FOR MORE THAN 20 MINS AND WAS RULED IN FOR MYOCARDIAL INFARCTION. CORONARY ANGIOGRAPHY WAS PERFORMED, WHICH REVEALED A 95% STENOSIS OF THE PROX. RCA AND 80% STENOSIS OF THE PROX LAD. THE LESION IN THE PROXIMAL LAD WAS DETERMINED TO BE WITHIN 5MM OF THE PREVIOUSLY PLACED CYPHER STENT IN THE MID-LAD (PERI-STENT STENOSIS). DURING THIS PROCEDURE, AN URGENT RE-PTCA WAS PERFORMED ON THE RCA. FIVE DAYS LATER, THE PATIENT WAS BROUGHT BACK TO THE CATH LAB FOR TREATMENT OF THE PROX LAD. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    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 S0203045

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R SIMVASTATINE| TICLOPIDINE| LIPID LOWERING AGENTS| ASPIRIN| LONG ACTING NITRATES| BETA-BLOCKER THERAPY