BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1153449 · Received September 5, 2008

    Report

    Report Number
    9616099-2008-02167
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    January 2, 2008
    Report Date
    August 11, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS OUS CYPHER SELECT PLUS SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. ALSO NOTE THAT THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MFR REPORT NUMBER IS 9616099-2008-02166. THIS FEMALE IN THE REGISTRY EXPERIENCED DISSECTION DURING THE IMPLANTATION OF A CYPHER SELECT STENT. MEDICAL HISTORY INCLUDED HYPERLIPIDEMIA AND DIABETES. DURING THE INDEX PROCEDURE, A 2.75/13 MM CYPHER STENTS WAS IMPLANTED IN THE PROXIMAL LAD. THE TARGET SITE WAS DESCRIBED AS A TYPE B1 LESION: AT A BIFURCATION REQUIRING DOUBLE GUIDEWIRE, 90% STENOSIS, 12 MM LESION LENGTH WITH THROMBUS PRESENT. THE LESION WAS PRE-DILATED PRIOR TO IMPLANTING THE STENT AT 10 ATM; WHICH RESULTED IN A TYPE A PROXIMAL DISSECTION. A 3.0/13 MM CYPHER WAS THEN IMPLANTED AT 14 ATM TO COVER THE DISSECTION. SOME INSUFFICIENT FLOW WAS NOTED BUT FINAL KISSING BALLOONS WERE USED AND THERE WAS NO RESIDUAL STENOSIS. POST PROCEDURE CK WAS 2 X ABOVE THE UNL. NO FURTHER COMPLICATIONS OCCURRED AND SHE WAS DISCHARGED ON ASA AND PLAVIX. THE STENT COULD NOT BE RETURNED FOR EVAL; IT REMAINED IMPLANTED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THIS LOT OF PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. VESSEL DISSECTION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. THE SAFETY AND EFFECTIVENESS OF CYPHER HAS NOT BEEN ESTABLISHED FOR USE IN PATIENTS WITH UNRESOLVED THROMBUS AT THE LESION SITE. DIABETES IS A PREMORBID CONDITION THAT INCREASES THE RISK OF A POOR INITIAL RESULT. REVIEW OF THE AVAILABLE INFO SUGGESTS THAT PT FACTORS AND VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A PATIENT WAS INITIALLY ENROLLED IN THE STUDY IN 2008, WITH 1-VESSEL DISEASE. THE MAIN INDICATION FOR THE INTERVENTION WAS UNSTABLE ANGINA PECTORIS. THE LESION INITIALLY TREATED WAS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) BRANCH. THE LESION HAD 90% STENOSIS AND WAS DE NOVO, BIFURCATED, SMOOTH AND ECCENTRIC WITH THROMBUS PRESENT. THE LESION WAS PRE-DILATED AND A 2.75 X 18 MM CYPHER SELECT PLUS STENT WAS ELECTIVELY IMPLANTED AT 10 ATM. IT WAS NOTED THAT THE STENT WAS POST-DILATED A TYPE A DISSECTION OCCURRED. AS A RESULT, A 3.0 X 13 MM CYPHER SELECT PLUS STENT WAS IMPLANTED AT 14 ATM TO TREAT THE DISSECTION. THIS STENT WAS POST-DILATED DUE TO INSUFFICIENT FLOW. POST PROCEDURE (6-24 HOURS) CK LEVELS WERE NOTED TO BE GREATER THAN TWO TIMES ABOVE THE UPPER NORMAL LEVEL. DURING A MONTHLY FOLLOW-UP, THE FOLLOWING MONTH, THE PT REPORTED EXPERIENCING ANGINA PECTORIS. IT WAS NOTED THAT THE PT WAS COMPLAINT WITH HER MEDICATIONS. THE PATIENT'S BASELINE MEDICATION INCLUDED ASPIRIN. THE PATIENT'S INTRA PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, AGGRASTAT AND HEPARIN. THE PT'S POST PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, INSULIN, STATINS, ACE INHIBITORS AND BETA-BLOCKERS.

    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 13291486

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention A 2.5 X 9MM BALLOON CATHETER| A 3.0 X 12MM BALLOON CATHETER| A 6F GUIDING CATHETER| A 2.0 X 9MM BALLOON CATHETER