BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 817726 · Received February 6, 2007

    Report

    Report Number
    9616099-2007-00250
    Event Type
    Injury
    Date Received
    February 6, 2007
    Report Date
    January 9, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS FROM A JOURNAL ARTICLE IN ANOTHER COUNTRY JOURNAL OF INTERVENTIONAL CARDIOLOGY. THE PATIENT WAS A MALE, 162CM 61.5KG. THE PATIENT'S MEDICAL HISTORY WAS HEART FAILURE (HF), CHEST DISCOMFORT, EFFORT DYSPNEA AND GENERALIZED FATIGUE. IN 2004, THE PATIENT COMPLAINED OF CHEST DISCOMFORT WHILE PLAYING GOLF. ONE MORNING, THE PATIENT FELFT BLOOD DRAIN AND CHEST DISCOMFORT AT THE SAME TIME. THERE WERE NO SYMPTOMS AFTER THAT AND A FEW DAYS LATER, THE PATIENT VISITED THE HOSPITAL AND ECG ABNORMALITY WAS OBSERVED. CORONARY ANGIOGRAPHY (CAG) WAS CONDUCTED AND TOTAL OCCLUSIONS (100% STENOSIS) WERE OBSERVED AT THE MID RIGHT CORONARY ARTERY (RCA), THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD), AND THE LEFT CIRCUMFLEX (CX). THERE WAS 90% STENOSIS AT THE POSTERO-LATERAL BRANCH AS WELL. THERE WERE COLLATERAL CIRCULATIONS BETWEEN RCA TO LAD AND LCX-RCA. BECAUSE 2 BRANCHES WERE TOTALLY OCCLUDED, THE PATIENT WAS DIAGNOSED WITH HF. A CABG WAS CONDUCTED AT THE LEFT INTERNAL THORACIC ARTERY (LITA) TO THE LAD, THE GASTROEPIPLOIC ARTERY (GEA) TO THE RCA AND FREE RA-POSTERO LATERAL. HOWEVER, 90% FOCAL STENOSIS WAS OBSERVED AT THE GEA GRAFT. THEREFORE, PCI WAS CONDUCTED TO TREAT THE STENOSIS AREA. FEMORAL APPROACH WAS CHOSEN FOR THE PROCEDURE. WHILE MANIPULATING A RUNTHROUGH GUIDEWIRE, A HIGH-LEVELED SPASM OCCURRED EASILY AND SO ISDN WAS ADMINISTERED FREQUENTLY INTO THE GEA DIRECTLY. THEN, PRE-DILATION WAS CONDUCTED WITH A 2.5 X 14MM VENTO BALLOON AT 8ATM FOR 30 SECONDS. A 3.0 X 18MM CYPHER STENT (LOT UNKNOWN) WAS IMPLANTED AT 8ATM FOR 30SECONDS. THE PCI WAS SUCCESSFULLY FINISHED AND THERE WAS NO PROBLEM ON THE PATIENT. THREE MONTHS LATER, EXERCISE ECG WAS CONDUCTED AND THE PATIENT WAS DOING WELL. SIX MONTHS LATER, FOLLOW UP CAG WAS CONDUCTED AND TOTAL OCCLUSION WAS OBSERVED INSIDE THE CYPHER AT GEA AND PATIENT DID NOT SHOW ANY SYMPTOMS. IT IS UNKNOWN HOW THE TOTAL OCCLUSION WAS TREATED. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    SIX MONTHS AFTER RECEIVING A 3.0 X 18MM CYPHER STENT, THE PATIENT HAD RESTENOSIS.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| L VENTO 2.5 X 14MM BALLOON| RUNTHROUGH GUIDEWIRE| JR4.0 5FR GUIDE CATHETER