BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 764525 · Received September 18, 2006

    Report

    Report Number
    9616099-2006-01037
    Event Type
    Injury
    Date Received
    September 18, 2006
    Date of Event
    June 9, 2004
    Report Date
    September 18, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THIS FEMALE PT HAD THE FOLLOWING MEDICAL HISTORY: PREVIOUS ANTERIOR Q-WAVE MI AND HYPERTENSION. THE PT HAD NEVER SMOKED. MEDICATIONS AT BASELINE INCLUDED BETA-BLOCKER, ASPIRIN, TICLOPIDINE, AND LIPID LOWERING AGENTS. PLAVIX AND TICLOPIDINE WERE GIVEN BEFORE THE PROCEDURE. A 3.0X33 MM CYPHER STENT (LOT NUMBER R0303432) WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) AT 12 ATM. A 2.5X13MM CYPHER STENT (LOT NUMBER R0203032) WAS IMPLANTED IN THE POSTERIOR DESCENDING ARTERY (PDA) AT 12 ATM. A 2.5X13MM CYPHER STENT (LOT NUMBER R0203032) WAS IMPLANTED IN THE CIRCUMFLEX AT 12 ATM. A 2.5X23MM CYPHER STENT (LOT NUMBER S1102003) WAS IMPLANTED IN THE OBTUSE MARGINAL AT 12 ATM. DIRECT STENTING WAS PERFORMED ON ALL FOUR LESIONS. THE PT WAS DISCHARGED WITHOUT ANGINAL COMPLAINTS. APPROX FOURTEEN MONTHS LATER, THE PT WAS HOSPITALIZED FOR CHEST PAIN. A BICYCLE STRESS TEST WAS PERFORMED, BUT WAS NON-CONCLUSIVE. THEREFORE, THE SUBJECT WAS TRANSFERRED TO THE INDEX PROCEDURE HOSPITAL FOR FURTHER EXAMINATION. THE DAY AFTER, THE PT UNDERWENT A DIAGNOSTIC ANGIO THAT REVEALED INTRASTENT RESTENOSIS IN THE 3.0X33MM CYPHER STENT LOCATED IN THE MID LAD. A RE-PTCA WAS PERFORMED. A 3.0X13MM CYPHER STENT WAS IMPLANTED IN THE MID LAD AT 18 ATM. REO-PRO WAS GIVEN DURING THIS PROCEDURE. THE PROCEDURE AND FURTHER HOSPITALIZATION WERE WITHOUT EVENTS. PT WAS DISCHARGED IN GOOD CONDITION.

    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 R0303432

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R BETA BLOCKING AGENTS| ASPIRIN| PLAVIX| TICLOPIDINE