BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1861387 · Received October 8, 2010

    Report

    Report Number
    3003742446-2010-00357
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    August 2, 2010
    Report Date
    September 10, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    A (B)(6) FEMALE FROM THE DAPT STUDY EXPERIENCED A MYOCARDIAL INFARCTION APPROXIMATELY FIVE MONTHS POST IMPLANTATION OF A CYPHER STENT IN THE SETTING OF SUFFERING FROM CHOLECYSTITIS. PAST MEDICAL HISTORY THAT MAY HAVE INCREASED HER RISK FOR MACE INCLUDES DIABETES MELLITUS TREATED WITH ORAL MEDICATIONS, HYPERTENSION, CORONARY ARTERY BYPASS GRAFT IN 2000, AND COLON CANCER (ON A PREVIOUS UNKNOWN DATE) TREATED WITH SURGICAL RESECTION. DURING THE INDEX PROCEDURE A LESION IN THE FIRST OBTUSE MARGINAL BRANCH WAS TREATED. A CYPHER STENT WAS IMPLANTED IN THE LESION AND THE POST PROCEDURE RESIDUAL STENOSIS WAS 0% WITH A TIMI FLOW OF 3. APPROXIMATELY FIVE MONTHS POST INDEX PROCEDURE THE PATIENT WAS ADMITTED WITH ACUTE CHOLECYSTOSIS, CHOLELITHIASIS AND BILIARY COLIC, COMPLICATED BY A NON Q-WAVE MYOCARDIAL INFARCTION. THE TROPONIN REPORTEDLY PEAKED TO 3.79 (UNITS UNKNOWN). THE EKG SHOWED DIFFUSE INFERIOR, ANTERIOR AND ANTEROLATERAL ST-T-WAVE CHANGES. AN ULTRASOUND SHOWED GALLSTONES, SLUDGE AND THICK-WALLED CHOLECYSTITIS. THE PATIENT HAD A LAPAROSCOPIC CHOLECYSTECTOMY. THE EVENTS RESOLVED AND THE PATIENT WAS DISCHARGED. MULTIPLE ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION REGARDING THE EVENT WERE UNSUCCESSFUL. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. MYOCARDIAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES. IT IS OUR INTENTION TO REPORT CONSERVATIVELY WITH INFORMATION IS NOT AVAILABLE. BASED ON THE LIMITED INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. HOWEVER, THERE ARE POSSIBLE PATIENT FACTORS, SPECIFICALLY THE ONSET OF CHOLECYSTITIS AND THE SERIOUS MEDICAL RISK FACTORS PRESENT IN THE MEDICAL HISTORY THAT MAY HAVE CONTRIBUTED TO THE REPORTED MYOCARDIAL INFARCTION. THE INFORMATION AVAILABLE FOR REVIEW DOES NOT INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE, IT WILL BE REPORTED ACCORDINGLY.

    Description of Event or Problem · 1

    APPROXIMATELY FIVE MONTHS POST INDEX PROCEDURE THE PATIENT WAS ADMITTED WITH ACUTE CHOLECYSTOSIS, CHOLELITHIASIS AND BILIARY COLIC, COMPLICATED BY A NON Q-WAVE MYOCARDIAL INFARCTION. THE TROPONIN REPORTEDLY PEAKED TO 3.79 (UNITS UNKNOWN). THE EKG SHOWED DIFFUSE INTERIOR, ANTERIOR AND ANTEROLATERAL ST-T-WAVE CHANGES. AN ULTRASOUND SHOWED GALLSTONES, SLUDGE AND THICK-WALLED CHOLECYSTITIS. THE PATIENT HAD A LAPAROSCOPIC CHOLECYSTECTOMY. THE EVENTS RESOLVED AND THE PATIENT WAS DISCHARGED. THE EVENTS WERE DEEMED TO BE UNRELATED TO THE DEVICE AND PROCEDURE. THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY, DUE TO UNSTABLE ANGINA, WITH A LESION IN THE FIRST OBTUSE MARGINAL BRANCH. A CYPHER STENT WAS IMPLANTED IN THE LESION AND THE POST PROCEDURE RESIDUAL STENOSIS WAS 0% WITH A TIMI FLOW OF 3. APPROXIMATELY EIGHTEEN DAYS POST INDEX PROCEDURE THE PATIENT WAS ADMITTED AND HOSPITALIZED FOR GASTROINTESTINAL BLEEDING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization