BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2033253 · Received March 30, 2011

    Report

    Report Number
    3003742446-2011-00138
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    May 11, 2010
    Report Date
    December 2, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS DIAGNOSED WITH AN MI POST-PROCEDURE. THE MI DIAGNOSIS WAS BASED ON A TROPONIN BUMP OF 0.14 (ULN 0.039) 16 TO 24 HOURS AFTER THE INDEX PROCEDURE. THERE WERE NO OTHER TROPONIN RESULTS BEFORE OR AFTER THE PROCEDURE. THERE WERE NO REPORTS OF CHEST PAIN, NO EKG CHANGE AND NO TESTING TO DETERMINE IF THE STENTS WERE PATENT AT THE TIME OF THE MI. THERE WAS NO TREATMENT FOR THE MI. THE PATIENT WAS DISCHARGED LATER THAT DAY. ACCORDING TO THE INVESTIGATOR THE MI WAS POSSIBLY RELATED TO THE CYPHER STENTS. CONCOMITANT MEDICATIONS INCLUDED CLOPIDOGREL 600MG, BIVALIRUDIN AND 325MG ASPIRIN AT THE TIME OF THE INDEX PROCEDURE AND ROSUVASTATIN 40MG, CARVEDILOL 6.25MG, ASPIRIN 75MG ON THE DAY OF THE MI. COMPLAINT CONCLUSION: AS REPORTED VIA THE (B)(4) STUDY, (B)(6) FEMALE PATIENT EXPERIENCED AN MI POST INDEX PROCEDURE. PAST MEDICAL HISTORY INCLUDES ANGINA, HYPERLIPIDAEMIA, AND HYPERTENSION. THE MI WAS DIAGNOSED BASED ON A TROPONIN BUMP OF 0.14 (ULN 0.039) 16 - 24 HOURS AFTER THE INDEX PROCEDURE. THERE WAS NO CHEST PAIN, NO EKG CHANGES AND NO TESTING TO DETERMINE IF THE STENTS WERE PATENT AT THE TIME OF THE MI. THERE WAS NO TREATMENT FOR THE MI AND THE PATIENT WAS DISCHARGED. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED TWO LEFT ANTERIOR DESCENDING (LAD) LESIONS. THE INDICATION FOR THE PROCEDURE WAS NON-ST ELEVATION ACUTE CORONARY SYNDROME AND NSTEMI THAT HAD OCCURRED 168 HOURS PRIOR TO THE INDEX PROCEDURE. THE PROXIMAL LAD LESION WAS 80% STENOSED, 15MM IN LENGTH, DE NOVO, AND MODERATELY CALCIFIED. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER. A 3.0 X 18MM CYPHER RX WAS IMPLANTED BY DIRECT STENTING AT 14 ATM AND WAS POST-DILATED PER STANDARD PROCEDURE WITH A 3.5 X 15MM BALLOON AT 16ATM. THERE WAS NO RESIDUAL STENOSIS. THE MID LAD LESION WAS 80% STENOSIS, 24MM IN LENGTH, MODERATELY CALCIFIED CLASS C AND DE NOVO. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. A 2.5 X 28MM CYPHER RX WAS IMPLANTED AT 8ATM BY DIRECT STENTING AND WAS POST-DILATED WITH A 2.5 X 20MM BALLOON AT 16ATM. THERE WAS NO RESIDUAL STENOSIS. PRE AND POST TIMI FLOW FOR BOTH LESIONS WAS 3. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THREE MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED STENOSIS OF THE OSTIUM OF THE FIRST DIAGONAL. THE FIRST DIAGONAL LESION WAS NOT WITHIN 5MM OF THE CYPHER STENTS WAS TREATED WITH A DRUG ELUTING STENT. THE CYPHER STENTS IMPLANTED IN THE MID LAD WERE PATENT. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. MYOCARDIAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES. LUMEN ENLARGEMENT DURING CORONARY STENTING RESULTS FROM VESSEL EXPANSION AND AXIAL REDISTRIBUTION OF ATHEROMATOUS PLAQUE ALONG THE STENTED SEGMENT AND PROXIMAL AND DISTAL SEGMENTS. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW. THIS ACTION CAN EXHIBIT ITSELF AS CHEST PAIN, EKG CHANGES AND/OR CARDIAC ENZYMES INCREASE LEADING TO DIAGNOSIS OF MYOCARDIAL INFARCTION. BASED ON THE INFORMATION PROVIDED, THERE ARE POSSIBLE PATIENT, VESSEL CHARACTERISTICS AND INHERENT RISK OF PROCEDURE FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00138 AND 3003742446-2011-00139.

    Description of Event or Problem · 1

    INITIALLY, THIS FILE DID NOT CONTAIN ANY INFORMATION THAT MET MDR REPORTABILITY CRITERIA. ADDITIONAL INFORMATION WAS PROVIDED ON 3/7/2011 THAT WAS MDR REPORTABLE. AS REPORTED VIA THE (B)(4) STUDY, A PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI) FOLLOWING THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED TWO LEFT ANTERIOR DESCENDING (LAD) LESIONS. THE INDICATION FOR THE PROCEDURE WAS NON-ST ELEVATION ACUTE CORONARY SYNDROME AND NSTEMI THAT HAD OCCURRED 168 HOURS PRIOR TO THE INDEX PROCEDURE. THE PROXIMAL LAD LESION WAS 80% STENOSED, 15MM IN LENGTH, DE NOVO, AND MODERATELY CALCIFIED. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER. A 3.0 X 18MM CYPHER RX WAS IMPLANTED BY DIRECT STENTING AT 14 ATM AND WAS POST-DILATED PER STANDARD PROCEDURE WITH A 3.5 X 15MM BALLOON AT 16ATM. THERE WAS NO RESIDUAL STENOSIS. THE MID LAD LESION WAS 80% STENOSIS, 24MM IN LENGTH, MODERATELY CALCIFIED CLASS C AND DE NOVO. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. A 2.5 X 28MM CYPHER RX WAS IMPLANTED AT 8ATM BY DIRECT STENTING AND WAS POST-DILATED WITH A 2.5 X 20MM BALLOON AT 16ATM. THERE WAS NO RESIDUAL STENOSIS. PRE AND POST TIMI FLOW FOR BOTH LESIONS WAS 3.

    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 15131030

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening