BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2964219 · Received February 15, 2013

    Report

    Report Number
    2024168-2013-00911
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    October 10, 2012
    Report Date
    January 22, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    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. 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. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA AND MYOCARDIAL INFARCTION ARE LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT WAS ADMITTED FOR A NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI). THE PATIENT HAD THREE PROMUS STENTS IMPLANTED ON (B)(6) 2011, IN A "V" STENTING TECHNIQUE IN THE OSTIAL/PROXIMAL RAMUS AND LEFT ANTERIOR DESCENDING ARTERY (LAD). APPROXIMATELY A YEAR LATER, ON (B)(6) 2012, THE PATIENT CALLED THE CARDIOLOGIST TO DISCONTINUE THE PLAVIX. ON (B)(6) 2012, THE PATIENT PRESENTED TO THE HOSPITAL WITH CHEST PAIN. IN THE EMERGENCY ROOM, MEDICATIONS WERE GIVEN FOR THE CHEST PAIN. CARDIAC ENZYMES WERE PERFORMED AND WERE NOTED TO BE ELEVATED. THE PATIENT WAS ALSO NOTED TO HAVE EKG CHANGES. A MYOCARDIAL INFARCTION (MI) WAS SUSPECTED. THE PATIENT DECLINED ANY FURTHER INTERVENTION AND WAS DISCHARGED TO A REHABILITATION FACILITY. AS THE PATIENT DID NOT PURSUE THE INTERVENTION OR CATHETERIZATION AFTER THE MI, IT IS UNKNOWN IF THE MI IS RELATED TO THE STENTS; HOWEVER CONTRIBUTING FACTORS COULD BE THE ANEMIA, CO-MORBID DISEASE PROGRESSION, AND STOPPING ANTIPLATELET MEDICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68367 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0071561

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| S STENT: PROMUS 3.5 X 18 MM, 3.5 X 23 MM