BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 866652 · Received June 15, 2007

    Report

    Report Number
    9616099-2007-01116
    Event Type
    Injury
    Date Received
    June 15, 2007
    Date of Event
    May 10, 2007
    Report Date
    May 22, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THIS PT PRESENTED TO THE CARDIAC CATHETERIZATION UNIT FOR UNSPECIFIED REASONS AND 1-VESSEL DISEASE WAS FOUND. INTRA-PROCEDURE MEDICATIONS INCLUDED CLOPIDOGREL 600MG AND UNFRACTIONATED HEPARIN. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON A 65% DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) OF 28MM IN LENGTH IN A 2.1MM VESSEL DIAMETER. THE (B2) ECCENTRIC LESION HAD AN IRREGULAR CONTOUR AND LITTLE TO NO CALCIFICATION. PRE-DILATION WAS CONDUCTED WITH A 2.5X15MM BALLOON AT 12 ATMOSPHERES (ATM) BEFORE A 2.5X33MM CYPHER SELECT STENT WAS DEPLOYED AT 14 ATM WITH SATISFACTORY RESULTS. RESIDUAL DIAMETER STENOSIS MEASURED 0%. POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS AND BETA-BLOCKERS. THE PT HAD SOME CHEST PAIN POST-PROCEDURE WITH ELEVATION OF ENZYMES CLASSIFIED AS NON Q-WAVE MYOCARDIAL INFARCTION AND IT WAS UNDETERMINED THAT IT WAS A TARGET VESSEL RELATED MYOCARDIAL INFARCTION. ANGIOGRAPHY WAS DONE THE FOLLOWING DAY WITH NO RESTENOSIS FOUND OR TREATMENT PROVIDED. PLEASE NOTE THAT THIS PROD (LOT # UNK) IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTE. A REPORT WAS REC'D THAT A MALE PT WITH A HISTORY OF OBESITY, PREVIOUS PCI, HYPERTENSION, HYPERLIPIDEMIA AND DIABETES EXPERIENCED A NON-Q MI THE DAYS OF HIS CYPHER STENT IMPLANTATION. INITIALLY, THE PT WAS ADMITTED WITH UNSTABLE ANGINA AND UNDERWENT AN ELECTIVE ANGIOGRAM THAT REVEALED A LESION IN HIS MID LAD. THIS PT'S HISTORY PUTS HIM AT INCREASED RISK FOR MACE. PRE PROCEDURAL MEDICATIONS INCLUDED ASA AND PLAVIX; WHILE INTRA PROCEDURAL MEDICATIONS INCLUDED ASA, PLAVIX AND UNFRACTIONATED HEPARIN. THE PT DID NOT RECEIVE A GPIIBIIIA DURING THE PROCEDURE AND THE PERFORMANCE OR RECORDING OF ACTS WAS NOT REPORTED. THE MID LAD LESION WAS DESCRIBED AS DE NOVO, 65% OCCLUDED, TYPE B2, 2.1MM IN DIAMETER, 28MM IN LENGTH, IRREGULAR, ECCENTRIC AND WITH LITTLE OR NO CALCIFICATION OR THROMBUS PRESENT. THE SAFETY AND EFFECTIVENESS OF THE CYPHER STENT HAS NOT BEEN ESTABLISHED IN THESE TYPES OF VESSELS AND/OR LESIONS. THE LESION WAS PRE-DILATED PRIOR TO THE PLACEMENT OF A 2.50X33MM CYPHER STENT AT A MAXIMUM INFLATION PRESSURE OF 14 ATM. THE TREATMENT OF THIS LESION WAS COMPLETED WITH A RESIDUAL STENOSIS OF 0%. LATER THAT SAME DAY, THE PT EXPERIENCED CHEST PAIN WITH INCREASED CARDIAC ENZYMES AND RULED IN FOR A NON-Q MI. THE AREA OF DISTRIBUTION WAS UNDETERMINED. AN ANGIOGRAM PERFORMED THE NEXT DAY REVEALED NO EVIDENCE OF THROMBOSIS OR RESTENOSIS. THIS EVENT WAS REPORTED TO BE UNRELATED TO THE CYPHER PROD. THE PROD REMAINS IMPLANTED IN THE PT AND IS THUS NOT AVAILABLE FOR EVAL. A DHR REVIEW COULD NOT BE PERFORMED SINCE THE LOT # WAS NOT PROVIDED. THERE ARE PT, VESSEL AND POSSIBLE PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    THE PT HAD CHEST PAIN POST PTCA (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY) WITH ELEVATION OF ENZYMES. ANGIOGRAPHY DONE THE FOLLOWING DAY REVEALED NO RESTENOSIS AND NO TREATMENT WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L