BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 846160 · Received April 30, 2007

    Report

    Report Number
    9616099-2007-00771
    Event Type
    Injury
    Date Received
    April 30, 2007
    Date of Event
    January 9, 2007
    Report Date
    April 6, 2007
    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

    THE INDEX PROCEDURE WAS AN ELECTIVE CASE. THE TARGET LESION FOR THE PROCEDURE WAS THE PROXIMAL TO DISTAL RCA. THE LESION WAS REPORTED TO BE: DE NOVO, ECCENTRIC, TORTUOUS, 60MM IN LENGTH. 2.5-3.0 MM IN DIAMETER, AND TYPE C. THE LESION WAS PRE-DILATED WITH A 2.5 X 15 MM BALLOON AT 20 ATM FOR 30 SEC. A CYPHER 2.5 X 18 MM STENT (STENT#1) WAS IMPLANTED AT 20 ATM FOR 30 SEC. A CYPHER 3.0 X 33MM STENT (STENT #2) WAS IMPLANTED AT 24 ATM FOR 24 ATM FOR 30 SEC AND 18 ATM FOR 30 SEC PROXIMAL TO THE FIRST CYPHER STENT IN OVERLAPPING FASHION. A CYPHER 3.0 X 18 MM STENT (STENT #3) WAS IMPLANTED AT 18 ATM FPR 30 SEC AND 10 ATM FOR 30 SEC PROXIMAL TO THE 2ND CYPHER STENT AND IN OVERLAPPING FASHION. POST-DILATATION WAS DONE WITH A 3.0 X 18 MM BALLOON AT 24 ATM FOR 30 SEC. IVUS WAS DONE. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. AN ACT WAS NOT MEASURED. PLEASE NOTE THAT THE 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. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT# 9616099-2007-00771 AND #9616099-2007-00772.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT APPROXIMATELY TWO (2) WEEKS AFTER THE INDEX PROCEDURE, THE PT RETURNED TO THE HOSPITAL FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE LEFT CORONARY ARTERY SYSTEM. THE PT WAS NOT SYMPTOMATIC. CORONARY ANGIOGRAPHY WAS DONE AND THROMBUS WAS OBSERVED IN THE SECOND (2ND) OF THE THREE (3) CYPHER STENTS IMPLANTED DURING THE INDEX PROCEDURE. THE STENT INVOLVED WAS A CYPHER 3.0 X 33 MM STENT THAT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA). THE SUB ACUTE THROMBOSIS WAS TREATED BY BALLOON ANGIOPLASTY WITH AN UNK INFLATION PRESSURE/DURATION. A VISION BARE METAL STENT WAS IMPLANTED INSIDE THE PREVIOUSLY IMPLANTED CYPHER STENT. ADDITIONAL INFO RECEIVED INDICATED THAT THE SAT WAS A FOCAL STENOSIS OF THE CYPHER 3.0 X 33 MM STENT AND THE VESSEL WAS TOTALLY OCCLUDED AT THAT SEGMENT. THERE WAS NO THROMBUS OR FRACTURE OBSERVED IN THE OTHER CYPHER STENTS. THE PT WAS REPORTED TO BE COMPLIANT WITH HIS ANTIPLATELET THERAPY. THE SECOND CYPHER 3.0 X 33 MM STENT (STENT #2) AND THE DISTAL/FIRST CYPHER 2.5 X 18 MM STENT (STENT #1) ARE BEING REPORTED DUE TO THE TOTAL OCCLUSION OF THE VESSEL AT THE LEVEL OF THE 2ND CYPHER STENT. THE PHYSICIAN'S COMMENT REGARDING THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS THE CYPHER 3.0 X 33 MM STENT MAY HAVE BEEN FRACTURED.

    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 I1106022

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R 2.5 X 15 MM BALLOON| ASPIRIN| 3.0 X 18 MM BALLOON| TICLID