BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1161179 · Received September 15, 2008

    Report

    Report Number
    9616099-2008-02250
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    April 21, 2008
    Report Date
    August 18, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDICATION FOR THE INDEX PROCEDURE WAS AN ACUTE NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) WITH ONSET OF SYMPTOMS GREATER THAN SEVENTY-TWO HOURS (>72 HOURS). THE PATIENT WAS FOUND TO HAVE THREE-VESSEL DISEASE AND HAD ONE LESION TREATED DURING THE PROCEDURE. NO STAGED PROCEDURE WAS PLANNED. THE PATIENT'S LEFT VENTRICULAR EJECTION FRACTION WAS GREATER THAN FIFTY PERCENT (LVEF>50%). THE TARGET LESION FOR THE PROCEDURE WAS THE MID LAD. THE LESION WAS REPORTED TO BE: DE NOVO, 3.0 MM VESSEL DIAMETER, 35 MM LENGTH, AN 80% STENOSIS, CONCENTRIC, AND TYPE B1. THE LESION WAS PRE-DILATED WITH A 2.5 X 15 MM BALLOON AT 17 ATM. A CYPHER SELECT PLUS 2.75 X 28 MM STENT (STENT #1) WAS IMPLANTED AT 20 ATM. ANOTHER CYPHER SELECT PLUS 3.0 X 13 MM STENT WAS IMPLANTED AT 22 ATM. THE STENTS WERE NOT OVERLAPPING. THE 2.75 X 28 MM CYPHER STENT WAS POST-DILATED WITH A 2.75 X 28 MM BALLOON AT 20 ATM DUE TO THE STENT NOT BEING FULLY EXPANDED. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC AT THE ONE, SIX AND TWELVE-MONTH FOLLOW-UPS AND WAS CONTINUING HIS MEDICAL REGIMEN. PLEASE NOTE THAT DEVICE (LOT# 13225820) IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. A MALE FROM THE REGISTRY EXPERIENCED IN-STENT RESTENOSIS APPROXIMATELY 10 MONTHS POST CYPHER STENTS IMPLANTATION. PAST MEDICAL HISTORY INCLUDES PREVIOUS PCI IN TARGET VESSEL AND DIABETES MELLITUS. THE PATIENT WAS DIAGNOSED WITH 3-VESSEL DISEASE. PCI WAS PERFORMED IN A TYPE B1 LESION WITH 80% STENOSIS IN THE MID LAD. THE LESION LENGTH WAS 35MM. ACCORDING TO THE IFU, THE PRODUCT IS INDICATED FOR USE IN DISCRETE LESION EQUAL TO OR LESS THAN 30MM IN LENGTH. THE PATIENT RECEIVED A 2.75X28MM AND A 3.0X13MM CYPHER SELECT PLUS DEPLOYED AT 20 AND 22 ATM. RESPECTIVELY. THE RATED BURST PRESSURE INDICATED IN THE IFU IS 16 ATMOSPHERES. THERE WAS A GAP BETWEEN THE TWO CYPHER STENTS. THE PRECAUTIONS SECTION OF THE IFU STATES THAT WHEN MULTIPLE STENTS ARE IMPLANTED, THE ENDS SHOULD OVERLAP SLIGHTLY. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY IN STABLE CONDITION. APPROXIMATELY 10 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND A CORONARY ANGIOGRAPHY REVEALED 70% IN-STENT RESTENOSIS. DUE TO THE SEVERITY OF THE PATIENT'S 3-VESSEL CORONARY ARTERY DISEASE, CABG WAS DEEMED THE BEST FORM OF TREATMENT AT THIS POINT. THERE WAS NO MORE INFORMATION AVAILABLE. THE DEVICES REMAIN IMPLANTED IN THE PATIENT AND ARE NOT AVAILABLE FOR INSPECTION. MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED FOR THE AFFECTED LOT NUMBERS AND THE PRODUCTS MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE PER THE APPLICABLE MANUFACTURING QUALITY PLAN. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. BASED ON THE INFORMATION PROVIDED, THERE ARE PATIENT (DIABETES AND SEVERE CAD) AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE PATIENT'S RESTENOTIC EVENT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 9616099-2008-02249. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE STUDY INDICATED THAT APPROXIMATELY TEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT HAD CORONARY ANGIOGRAPHY DONE DUE TO STABLE ANGINA. THE INFORMATION OBTAINED INDICATED THAT THE PATIENT HAD A 70% FOCAL (<10MM LENGTH), IN-STENT RESTENOSIS (ISR) OF THE PREVIOUSLY IMPLANTED TWO CYPHER SELECT PLUS STENTS: A 2.75 X 28 MM AND A 3.0 X 13 MM STENT. THE STENTS WERE IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE PATIENT WAS NEGATIVE FOR MYOCARDIAL INFARCTION. THE PATIENT WAS TREATED BY CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. ADDITIONAL INFORMATION WAS NOT AVAILABLE AS THE PATIENT WAS TREATED AT ANOTHER FACILITY.

    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 13225820

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 2.8 X 15 MM BALLOON