BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1033583 · Received April 23, 2008

    Report

    Report Number
    9616099-2008-01081
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 28, 2008
    Report Date
    March 28, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MALE PT OF UNK AGE AND MEDICAL HISTORY EXPERIENCED INTRA-PROCEDURAL PLAQUE SHIFT DURING A PCI. THE INDICATION FOR THE PROCEDURE WAS NOT REPORTED. PCI WAS PERFORMED ON A 90% DENOVO LESION IN THE LAD ADJACENT TO THE 1ST DIAGONAL. THE LESION WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS. TWO GUIDEWIRES WERE INSERTED INTO THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE 1ST DIAGONAL. PRE-DILATATION WAS CONDUCTED IN THE LAD BEFORE IMPLANTATION OF A 3.0X23MM CYPHER DEPLOYED ADJACENT TO THE 1ST DIAGONAL AT AN UNK PRESSURE. PLAQUE SHIFT INTO THE 1ST DIAGONAL WAS NOTED. TO TREAT THE PLALQUE SHIFT, PRE-DILATION WAS CONDUCTED IN THE 1ST DIAGONAL AND A 2.75X18 CYPHER WAS ATTEMPTED FOR IMPLANTATION BUT IT DID NOT CROSS THE LESION. BALLOON DILATION WAS CONDUCTED AND A SECOND ATTEMPT WAS MADE TO DELIVER THE STENT BUT WAS UNSUCCESSFUL, THEREFORE THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BALLOON DILATION ONLY. THERE WAS NO OTHER PT INJURY REPORTED. THE PROD REMAINS IMPLANTED IN THE PT AND IS THUS NOT AVAILABLE FOR EVAL. SEVERAL ATTEMPTS WERE MADE TO COLLECT LOT # INFO BUT WERE UNSUCCESSFUL; THEREFORE, IT IS NOT POSSIBLE TO PROVIDE A DHR. LUMEN ENLARGEMENT DURING CORONARY STENTING RESULTS FROM VESSEL EXPANSION AND AXIAL REDISTRIBUTION OF ATHEROMATOUS PLAQUE ALONG THE STENTED SEGMENT AND PROXIMAL AND DISTAL SEGMENTS. PCI OF LESIONS LOCATED NEXT TO A CORONARY BIFURCATION ALMOST INEVITABLY CAUSES PLAQUE SHIFTING IN THE SIDE BRANCHES. COMMON TECHNIQUES TO PREVENT PLAQUE SHIFTING DURING INTERVENTION OF BIFURCATION LESIONS INCLUDE DOUBLE GUIDE WIRE TECHNIQUE AND KISSING-BALLOON INFLATION. INFLATION OF BALLOONS OVER THE RECOMMENDED RATED BURST PRESSURE MAY LEAD TO EXCESSIVE INTIMAL DAMAGE AND HIGHER POTENTIAL FOR PLAQUE SHIFTING. BASED ON THE INFO PROVIDED, THERE ARE POSSIBLE VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    PCI WAS BEING PERFORMED ON A 90% DE NOVO LESION IN THE 1ST DIAGONAL. THE LESION WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS. TWO GUIDEWIRES (RUNTHROUGH AND ROUTE) WERE INSERTED INTO THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND IN THE 1ST DIAGONAL. PRE-DILATATION WAS CONDUCTED IN THE LAD WITH A 3.0MM RYUJIN BALLOON. THEN A 3.0X23MM CYPHER STENT WAS DEPLOYED IN THE LAD ADJACENT TO THE 1ST DIAGONAL. HOWEVER, PLAQUE SHIFT OCCURRED. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS CONDUCTED WITH A 2.5MM SPRINTER BALLOON AT 10 ATMOSPHERES IN THE 1ST DIAGONAL. THEN AN UNSUCCESSFUL ATTEMPT WAS MADE TO DELIVER A 2.75X18MM CYPHER STENT TO TREAT THE PLAQUE SHIFT. HOWEVER, IT DID NOT CROSS. POBA WAS CONDUCTED WITH THE INITIALLY USED STENT DELIVERY SYS AT 18 ATMOSPHERES (ATM) AND WITH A DIFFERENT SPRINTER BALLOON AT 12 ATM IN THE 1ST DIAGONAL. THE STENT COULD NOT BE REDELIVERED SO THE PROCEDURE WAS COMPLETED WITH CONDUCTING POBA ONLY. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATED. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED. ADD'L DETAILS ARE NOT AVAILABLE REGARDING THIS EVENT. IN ADDITION, THE DEVICE IS NOT AVAILABLE FOR TESTING AND EVAL.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R STENT: 2.75X18MM CYPHER| SPRINTER 2.5MM| GW: RUNTHROUGH| GC: LAUNCHER EBU3.5| BC: RYUJIN 3.0MM