BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1083523 · Received July 25, 2008

    Report

    Report Number
    9616099-2008-01835
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TARGET LESION WAS THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE LESION WAS REPORTED TO BE: DE NOVO, A 75% STENOSIS, HEAVILY CALCIFIED, AND VERY TORTUOUS. THE LESION WAS PRE-DILATED WITH A HIRYU 2.5 X 28 MM BALLOON/ATM UNKNOWN. A CYPHER 2.5 X 28 MM STENT WAS UNABLE TO ACCESS THE LESION. AN ADDITIONAL GUIDING CATHETER AND GUIDEWIRE WERE USED AND THE STENT WOULD NOT CROSS THE LESION. A CYPHER 2.5 X 18 MM STENT WAS THEN IMPLANTED SUCCESSFULLY. ADDITIONAL INFORMATION INCLUDING PATIENT DEMOGRAPHICS WAS REQUESTED BUT WAS UNAVAILABLE. PLEASE NOTE THAT 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. A PATIENT SUFFERED A CORONARY DISSECTION POST IMPLANTATION OF A CYPHER STENT. THE PATIENT'S DEMOGRAPHICS AND PAST MEDICAL HISTORY WERE UNKNOWN. PCI WAS PERFORMED IN THE PROXIMAL LAD DESCRIBED AS HEAVILY CALCIFIED, HIGHLY TORTUOUS AND 75% STENOSIS. THE SAFETY AND EFFECTIVENESS OF CYPHER HAS NOT BEEN ESTABLISHED IN PATIENTS WITH TORTUOUS VESSELS THAT MAY IMPAIR STENT PLACEMENT IN THE REGION OF OBSTRUCTION OR PROXIMAL TO THE LESION. PRE-DILATION WAS CONDUCTED BEFORE A 2.5X28MM CYPHER WAS DELIVERED BUT FAILED TO CROSS THE TARGET LESION. ADDITIONAL WIRE AND GUIDING CATHETER WERE INSERTED TO SUPPORT THE DELIVERY BUT CROSSING OF THE CYPHER STENT WAS NOT SUCCESSFUL. ANOTHER CYPHER STENT, A 2.5X18MM WAS USED AND SUCCESSFULLY IMPLANTED. HOWEVER, A SPIRAL DISSECTION AS NOTED AT THE DISTAL END OF THE STENT. TO TREAT THE DISSECTION, A NON-CORDIS STENT WAS IMPLANTED SUCCESSFULLY AND THE EVENT RESOLVED WITHOUT SEQUEL. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. DISSECTIONS ARE KNOWN POTENTIAL ADVERSE EVENTS DURING PCI. IN THE PRECAUTIONS SECTION OF THE IFU IT INDICATES THAT IMPLANTING A STENT MAY LEAD TO A DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENTED PORTION AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION, I.E. PLACEMENT OF ADDITIONAL STENTS. THIS IS AN INHERENT RISK OF THE PROCEDURE. BASED ON THE INFORMATION AVAILABLE, THERE ARE POSSIBLE VESSEL CHARACTERISTICS (HEAVY CALCIFICATION AND HIGHLY TORTUOUS VESSEL) AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING THE PATIENT'S INDEX PROCEDURE, A SPIRAL DISSECTION DISTAL TO THE CYPHER 2.5 X 18 MM STENT OCCURRED. THE DISSECTION WAS TREATED BY IMPLANTATION OF A LIBERTE STENT. THE PROCEDURE WAS THEN COMPLETED.

    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 13383724

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R BALLOON CATHETER: HURYU| GUIDEWIRE: RUNTHROUGH| GUIDING CATHETER: RADIGUIDE 6F| SHEATH: MEDIKIT