BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1910537 · Received November 30, 2010

    Report

    Report Number
    2024168-2010-02563
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 5, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. PHYSICIAN COMMENTS: THE PATIENT HAD MELENA AND THE BLEEDING AREA WAS INVESTIGATED. NOTHING ABNORMAL DETECTED IN THE RECTAL. IN ORDER TO PERFORM ENDOSCOPY, ADMINISTRATION OF ASPIRIN AND CLOPIDOGREL WERE DISCONTINUED. SINCE THE THROMBOSIS WAS CONFIRMED AFTER DISCONTINUATION OF HEPARIN, THE PHYSICIAN COMMENTED THAT IT MAY HAVE BEEN CAUSED BY DISCONTINUATION OF THE DRUGS, NOT DUE TO THE PROMUS. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND THROMBOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE 3.5 X 12 MM PROMUS (1009542-12B,UNK) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS A CHRONIC TOTAL OCCLUSION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON (B)(6) 2001. PROMUS 3.5 X 12 AND PROMUS 3.0 X 23 STENTS WERE IMPLANTED IN PROXIMAL TO MID LAD. AFTER THE PROCEDURE MELENA OCCURRED. IT IS UNKNOWN WHERE THE MELENA CAME FROM AND WHAT CAUSED MELENA. ON (B)(6) 2010, BLOOD STANCHING WAS PERFORMED. ANOSCOPY WAS PERFORMED, BUT IT WAS UNABLE TO FIND A CAUSE OF MELENA, AND ENDOSCOPY WAS SCHEDULED. FOR ENDOSCOPY, PLAVIX AND BAYAPIRINA WERE STOPPED, HEPARIN WAS ADMINISTERED. ON (B)(6) 2010, HEPARIN WAS STOPPED IN ORDER TO PERFORM ENDOSCOPY AND PATIENT HAD CHEST PAIN. CORONARY ANGIOGRAPHY WAS PERFORMED AND THROMBOTIC OCCLUSION WAS NOTED IN THE PROXIMAL LAD AND THIS WAS CONFIRMED TO BE SUB ACUTE STENT THROMBOSIS. AN THROMBUS ASPIRATION CATHETER WAS PERFORMED TO REMOVE THE THROMBOSIS. SINCE HIT (HEPARIN-INDUCED THROMBOCYTOPENIA) WAS SUSPECTED, ARGATROBAN WAS ADMINISTERED. TWO UNKNOWN BARE METAL STENTS WERE DEPLOYED IN THE PROMUS STENTS AND IN THE DISTAL LAD. THE TREATMENT WAS SUCCESSFUL AND TIMI FLOW WAS RESTORED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 3.5 X 12 MM PROMUS (1009542-12B,UNK)