BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1220483 · Received November 4, 2008

    Report

    Report Number
    9616099-2008-02597
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    February 12, 2008
    Report Date
    October 12, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 13198253 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WAS REQUESTED TO THE COATING SITE FOR CORONARY ARTERY RESTENOSIS. THE INVESTIGATION REVEALED THAT NO NONCONFORMANCES WERE ISSUED DURING THE COATING PROCESS, AND THAT NO ANOMALIES WERE FOUND FOR THE LOT INVOLVED. ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    SIX MONTH POST INDEX PROCEDURE, THE PATIENT HAD ECG, CORONARY ANGIOGRAPHY AND FOLLOWED BY A RE-PCI. THIS WAS A STAGED PROCEDURE-RE-PCI, THERE WAS NO EVIDENCE OF MYOCARDIAL INFARCTION (MI). THERE WAS DIFFUSE 80% STENOSIS OF FIRST OBTUSE MARGINAL BRANCH OF CFX. THE LESION WAS TREATED WITH ADD'L CYPHER STENT PLACEMENT. THE OUTCOME RESOLVED WITHOUT SEQUEL AND THE PATIENT WAS DISCHARGED THE NEXT DAY. THIS MALE PATIENT WITH STABLE ANGINA, HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, PAST SMOKER, DIABETES MELLITUS, 3 VESSEL DISEASE WAS UNDERGOING STENT PROCEDURE WITHIN THE FIRST OBTUSE MARGINAL BRANCH, NATIVE CORONARY ARTERY. THE TARGET VESSEL WAS PREVIOUSLY REVASCULARIZED WITH A COSTAR STENT, WHICH WAS PLACED PRIOR TO THIS PROCEDURE. THE LESION WAS 95% STENOSIS, (RESTENOTIC), READILY ACCESSIBLE, TYPE "B2". THE LESION WAS PRE-DILATED USING A 3 X 20 MM BALLOON AT 12 ATM. A CYPHER STENT WAS DEPLOYED IN THE LESION AT UNKNOWN ATM WITH SATISFACTORY RESULT. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH MEDICATION ASA 100MG, CLOPIDOGREL 75MG. PERMANENTLY. ONE-MONTH FOLLOW-UP THE PATIENT WAS ASYMPTOMATIC.

    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 13198253

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR 3.0 X 20MM BALLOON| 6FR GUIDING CATHETER