BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2231660 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06088
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE FIVE ADDITIONAL PROMUS STENTS ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ISCHEMIA, MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE PROMUS INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6), 2011 A PATIENT WITH DOUBLE VESSEL CORONARY ARTERY DISEASE WAS SUCCESSFULLY IMPLANTED WITH TWO PROMUS STENTS IN THE MID LEFT ANTERIOR DESCENDING (LAD) AND THE FIRST DIAGONAL ARTERIES. THE PATIENT RETURNED ON (B)(6), 2011 WITH ST- ELEVATED MYOCARDIAL INFARCTION (STEMI), LOW HEMOGLOBIN AND ALSO ANGINA. IMPLANTED STENTS WERE CONFIRMED TO BE THROMBOSED PER FLUOROSCOPY IMAGES TAKEN. A NEW PROMUS STENT WAS THEREFORE PLACED IN THE PROXIMAL LAD, THE MID LAD WAS BALLOONED, AND THREE PROMUS STENTS WERE IMPLANTED IN THE DISTAL LAD. HOWEVER, THE LAD WOULD NOT STAY OPEN AND INTERVENTION IN THE DIAGONAL ARTERY WAS UNSUCCESSFUL, AS THE DIAGONAL WAS JAILED WITH THE PROXIMAL STENT. THE PATIENTS MEDICATION WAS CHANGED FROM PLAVIX TO EFFIENT AFTER THE PROCEDURE. ON (B)(6), THE PATIENT WAS PRESENTED WITH SHORTNESS OF BREATH, REQUIRING INTUBATION. THE PATIENT WAS DIAGNOSED WITH A STEMI AND SHOWED SIGNS OF ISCHEMIA, WHICH REQUIRED A BALLOON PUMP. IN-STENT THROMBOSIS WAS IDENTIFIED IN THE TOTALLY OCCLUDED MID LAD. ATTEMPTS WERE MADE TO TREAT THE THROMBOSIS BY BALLOON INFLATIONS; HOWEVER, THE PATIENT ULTIMATELY REQUIRED EMERGENCY CORONARY ARTERY BYPASS SURGERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS REPORTEDLY DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 71 YR Hospitalization| R| S STENT: VERFLEX, PROMUS (X5)