BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2001341 · Received February 25, 2011

    Report

    Report Number
    3003742446-2011-00103
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    September 17, 2009
    Report Date
    February 1, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED COMPLAINT CONCLUSION: ADDITIONAL INFORMATION WAS RECEIVED VIA THE CEC ADJUDICATION MINUTES. THE COMMITTEE AGREED TO ARC (PERI-PROCEDURE PCI) TO BE RELATED TO THE PROCEDURE AND TO THE DEVICE. AS REPORTED VIA THE (B)(4) STUDY, A PATIENT EXPERIENCED ELEVATED CARDIAC ENZYMES AFTER THE INDEX PROCEDURE. PAST MEDICAL HISTORY INCLUDES ANGINA, PREVIOUS PCI TO NON-TARGET LESION, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, ST ELEVATED MYOCARDIAL INFARCTION, PVD/CLAUDICATION, ALLERGY TO SULFA DRUGS. AT THE TIME OF THE INDEX PROCEDURE, THE PATIENT HAD STENOSIS IN TWO LESIONS. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA PECTORIS. THE MID LEFT ANTERIOR DESCENDING (LAD) LESION WAS 18MM IN LENGTH, DE NOVO, 70% STENOSED, AND CLASS B1. PRE-PROCEDURE TIMI FLOW WAS 2 AND THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. A 2.5 X 23MM CYPHER RX WAS IMPLANTED BY DIRECT STENTING. THE LESION WAS NOT POST-DILATED AND THERE WAS NO RESIDUAL STENOSIS. CYPHER IS INDICATED FOR USE IN LESIONS JUDGED TO BE AMENABLE TO COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. POST PROCEDURE WAS TIMI 3 FLOW. THE FIRST DIAGONAL LESION WAS 80% STENOSED, DE NOVO, 14MM IN LENGTH AND CLASS B1. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. A 2.5 X 18MM CYPHER RX WAS IMPLANTED AT 9ATM BY DIRECT STENTING AND WAS POST-DILATED PER STANDARD PROCEDURE WITH A 2.5 X 12MM BALLOON AT 8ATM. PRE-PROCEDURE CK WAS 54 (ULN 308) AND CKMB WAS 3.22 (ULN 4.9). THE CK PEAKED AT 142, CKMB AT 17.81, AND TROPONIN AT 0.142 (ULN 0.01) POST-PROCEDURE. THE PATIENT WAS OBSERVED OVERNIGHT, BUT THERE WERE NO EKG CHANGES OR CARDIAC EVENTS REPORTED. THE PATIENT WAS DISCHARGED APPROXIMATELY TWO DAYS AFTER THE PROCEDURE. AT THE TIME OF THE ONE MONTH FOLLOW-UP, THE PATIENT REPORTED EXPERIENCED STABLE ANGINA; HOWEVER, CLINICAL CIRCUMSTANCES OF THE ANGINA WERE UNKNOWN AND NO TESTING OR TREATMENT WAS REPORTED. FIFTEEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS OF THE FIRST POSTERIO-LATERAL BRANCH OF THE RIGHT CORONARY ARTERY, A NON-TARGET VESSEL. THE INDEX PROCEDURE STENTS WERE NOTED TO BE PATENT. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS PRODUCT COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. 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 IS AN INHERIT RISK OF THE PROCEDURE. THIS ACTION CAN EXHIBIT ITSELF AS CHEST PAIN, EKG CHANGES AND CARDIAC ENZYMES INCREASE WHICH CAN LEAD TO A DIAGNOSIS OF PERI-PROCEDURAL MYOCARDIAL INFARCTION. PCI OF LESIONS LOCATED NEXT TO A CORONARY BIFURCATION ALMOST INEVITABLY CAUSES PLAQUE REDISTRIBUTION IN THE SIDE BRANCHES. COMMON TECHNIQUES TO PREVENT PLAQUE SHIFTING DURING INTERVENTION OF BIFURCATION LESIONS INCLUDE DOUBLE GUIDE WIRE TECHNIQUE AND KISSING-BALLOON INFLATION. BASED ON THE INFORMATION PROVIDED, THERE ARE POSSIBLE VESSEL CHARACTERISTICS (BIFURCATION) AND PROCEDURAL FACTORS (DIRECT STENTING) THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00102 AND 3003742446-2011-00103.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS AND DEVICES: 2.5 X 18MM CYPHER RX; METOPROLOL 12.5MG DAILY SINCE (B)(6) 2009; ZOCOR 40MG DAILY SINCE (B)(6) 2009; LISINOPRIL 2.5MG DAILY SINCE (B)(6) 2009; ASPIRIN 81MG DAILY SINCE (B)(6) 2009; ANGIOMAX 75MG INTRAVENOUSLY DURING PROCEDURE; CLOPIDOGREL 75MG SINCE (B)(6) 2009; THE VALID LOT NUMBER COULD NOT BE PROVIDED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00102 AND 3003742446-2011-00103. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED VIA THE (B)(6) STUDY, A PATIENT EXPERIENCED ELEVATED CARDIAC ENZYMES AFTER THE INDEX PROCEDURE. PAST MEDICAL HISTORY INCLUDES ANGINA, PREVIOUS PCI TO NON-TARGET LESION, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, ST ELEVATED MYOCARDIAL INFARCTION, PVD/CLAUDICATION, ALLERGY TO SULFA DRUGS. AT THE TIME OF THE INDEX PROCEDURE, THE PATIENT HAD STENOSIS IN TWO LESIONS. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA PECTORIS. THE MID LEFT ANTERIOR DESCENDING (LAD) LESION WAS 18MM IN LENGTH, DE NOVO, 70% STENOSED, AND CLASS B1. PRE-PROCEDURE TIMI FLOW WAS 2 AND THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. A 2.5 X 23MM CYPHER RX WAS IMPLANTED BY DIRECT STENTING. THE LESION WAS NOT POST-DILATED AND THERE WAS NO RESIDUAL STENOSIS. CYPHER IS INDICATED FOR USE IN LESIONS JUDGED TO BE AMENABLE TO COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. POST PROCEDURE WAS TIMI 3 FLOW. THE FIRST DIAGONAL LESION WAS 80% STENOSED, DE NOVO, 14MM IN LENGTH AND CLASS B1. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. A 2.5 X 18MM CYPHER RX WAS IMPLANTED AT 9ATM BY DIRECT STENTING AND WAS POST-DILATED PER STANDARD PROCEDURE WITH A 2.5 X 12MM BALLOON AT 8ATM. PRE-PROCEDURE CK WAS 54 (ULN 308) AND CKMB WAS 3.22 (ULN 4.9). THE CK PEAKED AT 142, CKMB AT 17.81, AND TROPONIN AT 0.142 (ULN 0.01) POST-PROCEDURE. THE PATIENT WAS OBSERVED OVERNIGHT, BUT THERE WERE NO EKG CHANGES OR CARDIAC EVENTS REPORTED. THE PATIENT WAS DISCHARGED APPROXIMATELY TWO DAYS AFTER THE PROCEDURE. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE A VALID LOT NUMBER COULD NOT BE PROVIDED. 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 CARDIAC ENZYMES INCREASE. BASED ON THE INFORMATION PROVIDED, THERE ARE POSSIBLE PATIENT, VESSEL AND PROCEDURE FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO A MANUFACTURING ISSUE, THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00102 AND 3003742446-2011-00103.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED VIA THE CEC ADJUDICATION MINUTES ON 9/7/2011. THE COMMITTEE AGREED TO ARC (PERI-PROCEDURE PCI) AND IT WAS REPORTED THAT PERI-PROCEDURAL MI WAS LISTED AS ONE OF THE DISCHARGE DIAGNOSES. THE ECG CORE LAB REPORTED NO NEW MAJOR ST-T ABNORMALITIES AND NO Q WAVES. THIS WAS PREVIOUSLY REPORTED AS ELEVATED CARDIAC ENZYMES.

    Description of Event or Problem · 1

    AS REPORTED VIA (B)(4) STUDY, A PATIENT EXPERIENCED ELEVATED CARDIAC ENZYMES AFTER THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, THE PATIENT HAD TREATMENT OF TWO LESIONS. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA PECTORIS. THE MID LEFT ANTERIOR DESCENDING (LAD) LESION WAS 18MM IN LENGTH, DE NOVO, 70% STENOSED, AND CLASS B1. PRE-PROCEDURE TIMI FLOW WAS 2, AND THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. A 2.5 X 23MM CYPHER RX WAS IMPLANTED BY DIRECT STENTING. THE LESION WAS NOT POST-DILATED AND THERE WAS NO RESIDUAL STENOSIS. POST PROCEDURE WAS TIMI 3 FLOW. THE FIRST DIAGONAL LESION WAS 80% STENOSED, DE NOVO, 14MM IN LENGTH AND CLASS B1. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. A 2.5 X 18MM CYPHER RX WAS IMPLANTED AT 9ATM BY DIRECT STENTING AND WAS POST-DILATED PER STANDARD PROCEDURE WITH A 2.5 X 12MM BALLOON AT 8ATM. PRE-PROCEDURE CK WAS 54 (ULN 308) AND CKMB WAS 3.22 (ULN 4.9). THE CK PEAKED AT 142, CKMB AT 17.81, AND TROPONIN AT 0.142 (ULN 0.01) POST-PROCEDURE. THE PATIENT WAS OBSERVED OVERNIGHT, BUT THERE WERE NO EKG CHANGES OR CARDIAC EVENTS REPORTED. THE PATIENT WAS DISCHARGED APPROXIMATELY TWO DAYS AFTER THE PROCEDURE. THE STENTS WERE NOTED TO BE PATENT APPROXIMATELY 15 MONTHS AFTER THE INDEX PROCEDURE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| O