BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 934695 · Received October 29, 2007

    Report

    Report Number
    9616099-2007-02109
    Event Type
    Injury
    Date Received
    October 29, 2007
    Date of Event
    October 4, 2007
    Report Date
    October 5, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDEX PROCEDURE WAS AN ELECTIVE CASE. THE TARGET LESION WAS THE PROXIMAL/MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE LESION WAS REPORTED TO BE: AN IN-STENT-RESTENOSIS (ISR) OF PREVIOUSLY IMPLANTED EXPRESS BMS, CONCENTRIC, 20MM IN LENGTH, VESSEL DIAMETER OF 3.0MM, AND TYPE B1. THE LESION WAS PRE-DILATED WITH A 2.0 X 15MM BALLOON AT 12 ATM FOR 30 SEC. A CYPHER 3.0 X 23MM STENT WAS IMPLANTED AT 12 ATM FOR 30 SEC. A TAXUS 2.5 X 22MM STENT WAS IMPLANTED AT 12 ATM FOR 30 SEC IN THE DISTAL LAD. IVUS WAS DONE. THE RESIDUAL STENOSIS WAS 25%. THE FLOW PROCEDURE WAS TIMI 2 AND POST-PROCEDURE TIMI 3. AN ACT WAS NOT MEASURED. ADD'L INFO OBTAINED INDICATED THAT THERE WAS NO REPORTED OCCLUSION, FLOW LIMITATION, OR THROMBUS OF THE 1ST DIAGONAL AFTER THE PROCEDURE OR THROMBUS IN THE CYPHER STENT BY IVUS. THE INDICATION FOR THE PROCEDURE WAS NOT KNOWN. THE PATIENT WAS PRE-MEDICATED WITH TICLOPIDINE AND ASPIRIN. THE NEED FOR AN ADD'L (TAXUS) STENT IN THE DISTAL LAD WAS NOT PLANNED BUT NECESSARY DUE TO A STENOSIS NOTED BY THE PHYSICIAN AFTER THE CYPHER STENT IMPLANTATION. THE ACUTE THROMBOSIS OCCURRED WHILE THE PATIENT WAS STILL IN THE CATH LAB. THE 1ST DIAGONAL WAS NOT OCCLUDED PRIOR TO TREATMENT OF THE CYPHER STENT ACUTE THROMBOSIS. THE SIDE BRANCH OCCLUSION OF THE 1ST DIAGONAL WAS REPORTED BY THE PHYSICIAN TO BE RELATED TO THE ANGIOPLASTY TREATMENT OF THE ACUTE THROMBOSIS. NO ADD'L MEDICATIONS WERE ADMINISTERED FOR TREATMENT OF THE THROMBOTIC EVENT. PLEASE NOTE THAT THE DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT FIVE (5) MINS AFTER AN ELECTIVE PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, CORONARY ANGIOGRAPHY WAS DONE AND THROMBUS WAS OBSERVED IN THE CYPHER 3.0 X 23 MM STENT THAT WAS JUST IMPLANTED. THE ACUTE THROMBOSIS WAS TREATED BY BALLOON ANGIOPLASTY USING SEVERAL INFLATIONS. DURING THIS RE-INTERVENTION, PLAQUE SHIFT OCCURRED AND BLOOD FLOW TO THE FIRST (1ST) DIAGONAL WAS IMPAIRED. A DRIVER 3.0 X 24 MM BARE METAL STENT (BMS) WAS IMPLANTED IN THE 1ST DIAGONAL AT 12 ATM FOR 20 SEC. THE PHYSICIAN'S COMMENT REGARDING POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS THAT IT MIGHT BE DUE TO PLAQUE RUPTURE.

    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 13268956

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 2.0 X 15MM BALLOON| TAXUS 2.5 X 22MM STENT| 3.25 X 14MM BALLOON