BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2353404 · Received November 30, 2011

    Report

    Report Number
    2024168-2011-08098
    Event Type
    Injury
    Date Received
    November 30, 2011
    Date of Event
    September 26, 2011
    Report Date
    November 7, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE PAROXYSMAL ATRIAL FIBRILLATION WAS CONSIDERED AN EVENT THAT REQUIRED INITIAL OR PROLONGED HOSPITALIZATION AND WAS AN IMPORTANT MEDICAL EVENT REQUIRING INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. ALTHOUGH BOTH EVENTS OF ATRIAL FIBRILLATION WERE CONSIDERED SEVERE IN INTENSITY, THEY WERE NOT RELATED TO THE STUDY DRUG, NOT RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE STUDY PROCEDURE. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. ANGINA AND ARRYTHMIAS ARE KNOWN ADVERSE PATIENT EVENTS AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICE CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT HAD STABLE ANGINA AND A POSITIVE STRESS TEST AND UNDERWENT THE INDEX PROCEDURE WITH THE DEPLOYMENT OF ONE DRUG-ELUTING STENT TO LEFT MAIN CORONARY ARTERY. RESIDUAL STENOSIS WAS 0 % WITH TIMI 3 FLOW. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH ATRIAL FIBRILLATION. THE PATIENT WAS ADMITTED OVERNIGHT WITH A FAST ATRIAL FIBRILLATION AFTER EATING A MEAL WHICH CONTAINED GLUTEN AND EXPERIENCING DIARRHEA. THE PATIENT WAS GIVEN ONE PUFF OF GLYCERIN TRINITRATE AND WITHIN 20 MINUTES SYMPTOMS OF HEART RACING, CHEST OR BACK PAIN WERE RELIEVED. THE PATIENT'S TROPONIN RESULT WAS NEGATIVE. ADDITIONALLY, IN THE EMERGENCY DEPARTMENT THE PATIENT WAS ADMINISTERED 5 MG OF INTRAVENOUS METOPROLOL TWICE, AND 25 MG OF ORAL METOPROLOL. THE EVENT WAS CONSIDERED RECOVERED/RESOLVED AND ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. THE EVENT OF ATRIAL FIBRILLATION WAS CONSIDERED AN EVENT THAT REQUIRED INITIAL OR PROLONGED HOSPITALIZATION AND AN IMPORTANT MEDICAL EVENT/REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. ON (B)(6) 2011, THE PATIENT WAS AGAIN ADMITTED TO THE HOSPITAL WITH ATRIAL FIBRILLATION. IT WAS REPORTED THAT THE PATIENT DEVELOPED CHEST PAIN; HOWEVER IT WAS RESOLVED WITH GLYCERYL TRINITRATE (GTN) PRIOR TO THE HOSPITALIZATION. THE PATIENTS TROPONIN WAS REPORTED AS NEGATIVE; ADDITIONALLY, THE PATIENT HAD CARDIOVERSION INTO SINUS RHYTHM. THE PATIENT WAS REPORTED TO HAVE HAD SYMPTOMATIC BRADYCARDIA AND WAS STOPPED ON SOTALOL. THE PATIENTS SOTALOL WAS RESTARTED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2011.

    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-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R