BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1181504 · Received September 25, 2008

    Report

    Report Number
    9616099-2008-02339
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 27, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RETURNED YET. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THE REPORT WE RECEIVED FROM THE AFFILIATE INDICATED THAT A FEMALE PATIENT WAS ADMITTED FOR TREATMENT OF AN IN-STENT RESTENOSIS IN THE POSTERO-LATERAL BRANCH. THE RESTENOTIC STENT HAD BEEN PLACED TWO YEARS AGO AT THE PROXIMAL END OF THE TARGET LESION. THE LESION WAS MODERATELY CALCIFIED AND TORTUOUS AND HAD 75% STENOSIS. THE LESION WAS GOING TO BE PRE-DILATED WITH A 2.0MM VOYAGER (2.0MM) BALLOON FIRST, BUT THE BALLOON COULD NOT CROSS DUE TO THE CALCIFICATION. A DIFFERENT BALLOON (LACROSSE 1.3MM) WAS USED AND THEN THE VOYAGER (2.0MM) WAS DELIVERED AGAIN AND INFLATED TO PRE-DILATE THE LESION. A 2.5 X 13MM CYPHER WAS DELIVERED TO THE TARGET LESION, AND THE BALLOON WAS INFLATED AT 10 ATM WITHOUT PROBLEM. THEN, THE STENT DELIVERY SYSTEM (SDS) WAS PULLED TO THE PROXIMAL END A LITTLE AND THE BALLOON WAS INFLATED AGAIN. WHILE DEFLATING THE SDS BALLOON, THE PHYSICIAN FELT THE DEFLATION TOOK A LITTLE LONGER THAN USUAL. NEVERTHELESS, THE BALLOON DEFLATED COMPLETELY AND THE SDS WAS WITHDRAWN, BUT THE PHYSICIAN FELT LARGE FRICTION AND THE SDS BECAME STUCK AND WOULD NOT MOVE. THE PHYSICIAN INFLATED AND DEFLATED THE BALLOON AGAIN AND PULLED THE SDS FORCIBLY, BUT THE SDS WOULD NOT MOVE. THEN, ANOTHER EXPERIENCED PHYSICIAN TRIED AND PULLED THE SDS BUT FELT LARGE FRICTION AS WELL AND THE SDS WOULD NOT MOVE. EVENTUALLY, THE SDS WAS REMOVED BY PULLING WITH FORCE. THE PROCEDURE COMPLETED SAFELY AND THERE WAS NO RESIDUE INSIDE THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED. THE PHYSICIAN INDICATED THAT THERE WAS EXCESS RESISTANCE FELT AND WOULD LIKE INVESTIGATION OF THE EVENT, ESPECIALLY THE DEVICE'S GUIDEWIRE PORT AND THE BALLOON. THE SALES REP INDICATED THAT IT IS NOT LIKELY THAT THE CYPHER BECAME STUCK INSIDE THE PREVIOUS STENT.

    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 13357181

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK EVEREST INFLATION DEVICE| LACROSS 1.3MM BALOON CATHETERS| VOYAGER 2.0MM| SHERPA JL 4 GUIDING CATHETERS 6FR| ATHELETE GT| SUPERSOFT AND WHISPER LS GUIDEWIRES