BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021017 · Received March 26, 2008

    Report

    Report Number
    9616099-2008-00717
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    August 28, 2004
    Report Date
    March 31, 2005
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. A MALE PATIENT FROM THE CLINICAL STUDY EXPERIENCED IN-STENT RESTENOSIS APPROXIMATELY A YEAR AND A HALF POST IMPLANTATION OF A CYPHER STENT. TO TREAT THE RESTENOSIS, THE PATIENT UNDERWENT CABG TREATMENT. THE INDICATION FOR THE INDEX PROCEDURE WAS THE TREATMENT OF AN IN-STENT RESTENOSIS OF AN UNKNOWN STENT IMPLANTED TWO MONTHS EARLIER. INVESTIGATION EFFORTS CONTINUE TO CONFIRM IF THIS STENT WAS A CORDIS PRODUCT. PAST MEDICAL HISTORY INCLUDES INSULIN DEPENDENT DIABETES MELLITUS, HYPERTENSION, HYPERLIPIDEMIA, FAMILY HISTORY OF ISCHEMIC HEART DISEASE AND PREVIOUS MI. THIS PATIENT'S HISTORY PUTS HIM AT INCREASED RISK FOR MACE. PCI WAS PERFORMED IN THE MID LAD DESCRIBED AS 70% STENOSED, THE VESSEL DIAMETER WAS 3.0MM AND THE LESION LENGTH WAS 33MM. ACCORDING TO THE IFU, THIS PRODUCT IS INDICATED FOR USE IN DISCRETE LESIONS EQUAL TO OR LESS THAN 30 MM IN LENGTH. THE LESION WAS PRE-DILATED BEFORE THE IMPLANTATION OF A 3.0X33MM CYPHER. NO POST-DILATION WAS CONDUCTED. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI III FLOW WAS MAINTAINED PRE, INTRA POST-PROCEDURAL MEDICAL TREATMENT WAS NOT REPORTED. APPROXIMATELY A YEAR AND A HALF POST INDEX PROCEDURE, THE PATIENT HAD A CORONARY ANGIOGRAM. NO ANGINAL COMPLAINTS WERE REPORTED. AT 100% RESTENOSIS OF THE TARGET LESION IN THE LAD WAS OBSERVED. THE PHYSICIAN CONSIDERED CABG TO THE PROXIMAL LAD AND THE PROXIMAL RCA TO BE THE BEST CHOICE OF TREATMENT AT THIS TIME. A SUCCESSFUL CABG WAS PERFORMED A WEEK LATER. NO OTHER COMPLAINTS WERE REPORTED. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. RESTENOSIS IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. PATIENT'S WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDED THOSE WITH DIABETES, LONG LESIONS, SMALL VESSEL, BIFURCATIONS, AND RESTENOTIC LESIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT PATIENT FACTORS (SPECIFICALLY DIABETES, GENETIC PREDISPOSITION AND HIGH RISK FOR MACE) AND VESSEL/LESION CHARACTERISTICS (LONG RESTENOTIC LESION) MAY HAVE CONTRIBUTED TO THIS PATIENT'S RESTENOSIS.

    Description of Event or Problem · 1

    THE MALE PATIENT WAS INCLUDED IN STUDY IN 2003. DURING THE INDEX PROCEDURE, THE MID LAD WAS TREATED FOR IN-STENT RESTENOSIS (INITIAL STENT PLACED IN APPROX TWO MONTHS EARLIER) WITH A 3.0 X 33MM CYPHER STENT. THE PATIENT WAS HOSPITALIZED FOR TWENTY DAYS IN 2004. A REPEAT ANGIO WAS PERFORMED ON THE FIRST DAY IN THE HOSP. THE PATIENT HAS NO ANGINAL COMPLAINTS. DURING THIS PROCEDURE, THE DIAMETER STENOSIS OF THE TARGET LESION (LAD) WAS 100%. NO RE-PCI WAS PERFORMED DURING THIS PROCEDURE. THE PATIENT WAS HOSPITALIZED FOR FOURTEEN DAYS IN 2004 FOR A CABG. THIS CABG (INVOLVED TARGET LESION) WAS PERFORMED ON DURING HOSPITALIZATION. THE PATIENT HAD NO ANGINAL COMPLAINTS. RELATIONSHIP TO STUDY DEVICE AND INDEX PROCEDURE WAS HIGHLY PROBABLE.

    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 R1202558

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R