BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1053321 · Received May 22, 2008

    Report

    Report Number
    9616099-2008-01369
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 1, 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 PRODUCT IS EXPECTED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS.

    Description of Event or Problem · 1

    RADIAL APPROACH WAS CHOSEN FOR THE PROCEDURE. THE GUIDING CATHETER (GC) (LAUNCHER 5 FRENCH (JL) JUDKINS LEFT 3.5) WAS USED FOR THE PROCEDURE. THE TARGET LESION WAS CROSSED WITH A GUIDEWIRE (GW). INTRAVASCULAR ULTRASOUND (IVUS) WAS CONDUCTED AND PRE-DILATION WITH A BALLOON (MERCURY 2.0/15MM) WAS CONDUCTED. A CYPHER (2.5X23MM) WAS BEING DELIVERED TO THE TARGET LESION FOR IMPLANT, BUT THE CYPHER BECAME STUCK PROXIMAL TO MID LAD AND IT WOULD NOT ADVANCE FURTHER. THEREFORE, THE CYPHER WAS BEING REMOVED FROM THE PATIENT, BUT THE PROXIMAL END OF THE STENT BECAME STUCK AT THE TIP OF THE GC AND THE CYPHER COULD NOT BE RETRIEVED INTO THE GC. THEN THE PHYSICIAN TRIED TO REMOVE THE ENTIRE SYSTEM INCLUDING THE GC, BUT THE STENT DISLODGED AS IT WAS PASSING THE BRACHIAL ARTERY. THEREFORE, ONLY THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT LEAVING BOTH THE GC AND THE GW. THE DISLODGED STENT WAS REMOVED WITH SNARE OUT OF THE PATIENT SAFELY. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS CONDUCTED AND THE LESION WAS SATISFACTORY DILATED AND WAS CONFIRMED WITH ANGIOGRAPHY. THE PROCEDURE WAS FINISHED. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THE TARGET LESION WAS MID (LAD) LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS A DE NOVO. THE VESSEL WAS SLIGHTLY CALCIFIED BUT NOT TORTUOUS. THERE WAS 90% STENOSIS.

    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 13350750

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention STENT: CYPHER 2.5/23MM| GC: LAUNCHER 5F JL3.5| BC: MERCURY 2.0/15MM| GW: RINATO