BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2093780 · Received May 18, 2011

    Report

    Report Number
    3003742446-2011-00259
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    December 29, 2010
    Report Date
    March 25, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT NO CAUSE WAS PROVIDED FOR THE CONGESTIVE HEART FAILURE. ECHOCARDIOGRAM WAS PERFORMED THAT REVEALED NORMAL VENTRICULAR SIZE WITH MILDLY DIMINISHED GLOBAL LEFT VENTRICULAR SYSTOLIC DYSFUNCTION. EJECTION FRACTION OF 45% TO 50%, GRADE 2 DIASTOLIC FUNCTION, AND MILD AORTIC VALVE SCLEROSIS, BUT NO AORTIC STENOSIS. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00258 AND 3003742446-2011-00259. AS REPORTED BY THE (B)(4) STUDY, THE PATIENT EXPERIENCED CONGESTIVE HEART FAILURE EIGHT MONTHS AFTER THE INDEX PROCEDURE. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, HYPERLIPIDEMIA, HYPERTENSION, TYPE I DIABETES MELLITUS, AND LOW POTASSIUM LEVEL. THE TARGET LESIONS WERE LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND FIRST OBTUSE MARGINAL (OM). THE LESION IN THE MID LAD WAS DESCRIBED AS TYPE A, DE NOVO, NON-THROMBOSED, 18MM IN LENGTH, 90% STENOSED, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED WITH A 3.5X12MM UNKNOWN BALLOON CATHETER AND A 3.0X18MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 16ATMS. NO POST-DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. PRE AND POST- PROCEDURE TIMI FLOW WAS 3. THE LESION IN THE FIRST OBTUSE MARGINAL WAS DESCRIBED AS DE NOVO, TYPE B1, NON-THROMBOSED, 12MM IN LENGTH, 95% STENOSED, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED WITH A 3.5X12MM UNKNOWN BALLOON CATHETER AND A 3.0X13MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 16ATMS. THE LESION WAS POST-DILATED WITH AN UNKNOWN 3X12MM BALLOON CATHETER AT 16ATMS. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. EIGHT MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT WAS HOSPITALIZED FOR ACUTE DECOMPENSATED CONGESTIVE HEART FAILURE (CHF). NO TREATMENT WAS GIVEN AND THE EVENT RESOLVED WITHOUT SEQUELAE. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT. NO CATHETERIZATION WAS DONE AT THE TIME OF THE CHF; THEREFORE, IT WAS UNKNOWN IF THE CYPHER RX STENTS IMPLANTED IN THE MID LAD AND FIRST OBTUSE MARGINAL WERE PATENT AT THE TIME OF THE CHF. THE PATIENT WAS DISCHARGED HOME AFTER TWO DAYS IN THE HOSPITAL. THE PATIENT WAS TREATED WITH AGGRESSIVE DIERESIS. ULTRASOUND OF THE LEG WAS PERFORMED AND WAS NEGATIVE FOR DEEP VEIN THROMBOSIS. CT OF THE CHEST SHOWED SOME PLEURAL EFFUSION, OTHERWISE NEGATIVE. THE PATIENT WAS DISCHARGED WITH AN EXTRA DOSE OF POTASSIUM. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT NO CAUSE WAS PROVIDED FOR THE CONGESTIVE HEART FAILURE. ECHOCARDIOGRAM WAS PERFORMED THAT REVEALED NORMAL VENTRICULAR SIZE WITH MILDLY DIMINISHED GLOBAL LEFT VENTRICULAR SYSTOLIC DYSFUNCTION. EJECTION FRACTION OF 45% TO 50%, GRADE 2 DIASTOLIC FUNCTION, AND MILD AORTIC VALVE SCLEROSIS, BUT NO AORTIC STENOSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THESE LOTS PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. CONGESTIVE HEART FAILURE IS RELATED TO INABILITY OF THE HEART MUSCLE TO EFFECTIVELY PUMP BLOOD INTO THE SYSTEMIC CIRCULATION. THERE ARE MANY FACTORS THAT CAN AFFECT THIS, SUCH AS VIRAL/BACTERIAL INFECTION, DRUGS OR ALCOHOL, SYSTEMIC HYPERTENSION THAT HAS NOT BEEN TREATED OR MEDICALLY MANAGED, RENAL FAILURE, AND MYOCARDIAL INFARCTIONS. STENTS ARE IMPLANTED TO MAINTAIN THE PATENCY OF THE PLUMBING (ARTERIES) THAT FEED THE HEART MUSCLE. SINCE THERE IS NO ANGIOGRAPHIC EVIDENCE ESTABLISHING THE PATENCY OF THE STENTS, THIS INFORMATION WILL BE CAPTURED AS A COMPLAINT. WITH THE INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE AN EXACT CAUSE FOR THE EVENT BUT PATIENT FACTORS SUCH AS HYPERTENSION CAN'T BE DISCOUNTED. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, THE PATIENT EXPERIENCED CONGESTIVE HEART FAILURE EIGHT MONTHS AFTER THE INDEX PROCEDURE. THE TARGET LESIONS WERE LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND FIRST OBTUSE MARGINAL. THE LESION IN THE MID LAD WAS DESCRIBED AS TYPE A, DE NOVO, NON-THROMBOSED, 18MM IN LENGTH, 90% STENOSED, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED WITH A 3.5X12MM UNKNOWN BALLOON CATHETER AND A 3.0X18MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 16ATMS. NO POST-DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. PRE AND POST- PROCEDURE TIMI FLOW WAS 3. THE LESION IN THE FIRST OBTUSE MARGINAL WAS DESCRIBED AS DE NOVO, TYPE B1, NON-THROMBOSED, 12MM IN LENGTH, 95% STENOSED, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED WITH A 3.5X12MM UNKNOWN BALLOON CATHETER AND A 3.0X13MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 16ATMS. THE LESION WAS POST-DILATED WITH AN UNKNOWN 3X12MM BALLOON CATHETER AT 16ATMS. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. EIGHT MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT WAS HOSPITALIZED FOR ACUTE DECOMPENSATED CONGESTIVE HEART FAILURE. NO TREATMENT WAS GIVEN AND THE EVENT RESOLVED WITHOUT SEQUELAE. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT. NO CATHETERIZATION WAS DONE AT THE TIME OF THE CHF; THEREFORE, IT WAS UNKNOWN IF THE CYPHER RX STENTS IMPLANTED IN THE MID LAD AND FIRST OBTUSE MARGINAL WERE PATENT AT THE TIME OF THE CHF. THE PATIENT WAS DISCHARGED HOME AFTER TWO DAYS IN THE HOSPITAL. THE PATIENT WAS TREATED WITH AGGRESSIVE DIERESIS DUE TO SEVERE LOW POTASSIUM LEVELS. ULTRASOUND OF THE LEG WAS PERFORMED AND WAS NEGATIVE FOR DEEP VEIN THROMBOSIS. CT OF THE CHEST SHOWED SOME PLEURAL EFFUSION, OTHERWISE NEGATIVE. THE PATIENT WAS DISCHARGED WITH AN EXTRA DOSE OF POTASSIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15087076

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R