BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1153447 · Received September 5, 2008

    Report

    Report Number
    9616099-2008-02173
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    December 18, 2007
    Report Date
    July 23, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER OF THE PRODUCTS COULD BE RETURNED FOR EVAL; THEY REMAINED IMPLANTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION INDICATED THAT THESE LOTS MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. RESTENOSIS IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. REVIEW OF THE LIMITED INFO SUGGESTS THAT EITHER PRE-EXISTING CORONARY DISEASE OR PROGRESSION OF DISEASE MAY HAVE CONTRIBUTED TO THIS EVENT. THIS IS ONE OF TWO PRODUCTS INVOLVED IN THE SAME PT AND REPORTED UNDER MANUFACTURING NUMBER 9616099-2008-02172 AND 9616099-2008-02173.

    Description of Event or Problem · 1

    THIS FEMALE IN THE REGISTRY EXPERIENCED AN APPARENT RESTENOSIS POST IMPLANTATION OF 2 CYPHER STENTS. MEDICAL HISTORY LISTED ONLY HYPERTENSION AND A RISK FACTOR OF FAMILY HISTORY+ FOR HEART DISEASE. DURING THE INDEX PROCEDURE, TWO CYPHER SELECT+ STENTS (3.0/28 AND 3.0/8MM) WERE IMPLANTED IN THE PT'S MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE TARGET SITE WAS DESCRIBED AS A TYPE B1 LESION: TOTAL OCCLUSION OF UNKNOWN DURATION BUT WITH "80%" STENOSIS AND "100MM LESION" LENGTH. THE LESION WAS PREDILATED PRIOR TO IMPLANTING THE STENTS IN AN ABUTTING MANNER AT 14 ATM. THE END RESULT WAS SATISFACTORY AND NO COMPLICATIONS WERE REPORTED. THE PT WAS DISCHARGED ON ASA AND PLAVIX. APPROXIMATELY 2 MONTHS LATER, THE DATABASE NOTES, "IN 2007, RE-PCI IN OTHER HOSPITAL. IN THE RDA 9D1 AND 10D2 OCCLUSION UNTIL 50-69%. NO TREATMENT NECESSARY." INVESTIGATION INTO THIS EVENT WAS UNABLE TO CONCLUSIVELY DETERMINE THAT STATUS OF THE LAD STENTS OR THE POSSIBILITY OF PERI-STENT RESTENOSIS. AS REPORTED, "FROM THE DESCRIPTION OF THE ANATOMY FROM A PREVIOUS LETTER, I ASSUME THAT THE D1 STENOSIS WAS WITHIN 5MM PROXIMITY OF THE STENT, BUT IT WAS PRE-EXISTENT."

    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 13224386

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other GUIDING CATHETER SIZE (FR)| BALLOON CATHETER MAX (2.5/20) MM MFR UNK