BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1221203 · Received November 5, 2008

    Report

    Report Number
    9616099-2008-02599
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 10, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS A FEMALE. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS DE NOVO, HEAVILY CALCIFIED AND HIGHLY TORTUOUS. THERE WAS 99% STENOSIS. IVUS WAS CONDUCTED INITIALLY. PRE-DILATION WITH A BALLOON (RYUJIN: 2.0 X15MM) WAS CONDUCTED, AND A 2.5 X 18MM CYPHER STENT WAS BEING DELIVERED, HOWEVER, THE CYPHER DID NOT ADVANCE FURTHER THAN THE OSTIUM AT THE LAD DUE TO HEAVY CALCIFICATION. THE PHYSICIAN PUSHED THE CYPHER BACK AND FORTH TO DELIVER THE CYPHER PASS THE CALCIFIED AND BIFURCATED PART AND SO THE PROXIMAL EDGE OF THE STENT BECAME FLARED. THEREFORE, THE PHYSICIAN DECIDED TO WITHDRAW THE CYPHER STENT. WHILE THE CYPHER WAS BEING PULLED BACK INSIDE THE GUIDING CATHETER, THE PROXIMAL EDGE OF THE STENT BECAME CAUGHT ON THE DISTAL TIP OF THE GUIDING CATHETER AND DISLODGED FROM THE STENT DELIVERY SYSTEM. THE DISLODGED STENT WAS RETRIEVED BY A SNARE CATHETER, AND THE ENTIRE SYSTEM WAS WITHDRAWN AS ONE UNIT. THEN ADDITIONAL PRE-DILATION WITH A BALLOON (HIRYU 2.25 X 10MM) WAS CONDUCTED, AND ANOTHER A 2.5 X 8MM CYPHER STENT WAS BEING DELIVERED. HOWEVER, IT DID NOT CROSS THE TARGET LESION. THE PHYSICIAN REPLACED A GUIDE WIRE (RUNTHROUGH) WITH OTHER WIRES (NEO'S FIELDER, THEN GRAND SLAM) AND TRIED TO REDELIVER THE CYPHER BUT CROSSING THE LESION WAS NOT SUCCESSFUL. THE PROCEDURE WAS SUCCESSFULLY FINISHED BY CONDUCTING BALLOON ANGIOPLASTY WITH A HIRYU 2.5 X 6MM BALLOON. THERE WAS NO PT INJURY REPORTED. BOTH CYPHERS WERE CLINICALLY USED, AND THEY WILL BE RETURNED FOR ANALYSIS. ONLY THE DELIVERY SYSTEM WILL BE RETURNED FOR THE 1ST COMPLAINT PRODUCT (THE DISLODGED STENT WAS DISCARDED MISTAKENLY IN THE HOSPITAL). THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS AVAILABLE FOR ANALYSIS. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE CYPHER STENT DISLODGED AND WAS RETRIEVED WITH A SNARE CATHETER.

    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 13412116

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention RUNTHROUGH| GRAND STAM GUIDEWIRES| RYUJIN| NEO'S FIELDER| HIRYU BALLOONS