BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1941502 · Received December 29, 2010

    Report

    Report Number
    2024168-2010-02974
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    November 26, 2010
    Report Date
    December 6, 2010
    Manufacturer
    AV-TEMECULA-CT
    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). THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND THROMBOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU). REPORTEDLY, THE PATIENT VESSEL DIAMETER AND LESION LENGTH WERE 3.0MM AND 46MM. THE PROMUS STENTS USED IN THIS CASE WERE BOTH 2.5X23MM. IT SHOULD BE NOTED THAT THE COMPLIANCE CHART IN THE IFU LISTS THE STENT IMPLANT INNER DIAMETER FOR A 2.5MM STENT AT 2.81MM WHEN INFLATED TO THE RATED BURST PRESSURE (RBP). IT IS UNKNOWN HOW, IF AT ALL, IMPLANTING A STENT WITH A SMALLER DIAMETER THAN THE VESSEL CONTRIBUTED TO THE REPORTED COMPLAINT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DIL CATH: SPRINTER LEGEND 2.0 X15; GUIDE WIRE: BMW UNIVERSAL 2; GUIDE CATH: LAUNCHER EBU 3.5 7F; STENT: 2.5 X 23 MM PROMUS (1009539-23B,0062961). THE OTHER 2.5 X 23 MM PROMUS (B)(4) REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, TWO PROMUS STENTS WERE IMPLANTED DURING A SCHEDULED PROCEDURE. PRE-DILATATION WAS PERFORMED WITH A 2.0 X 15MM NON-ABBOTT BALLOON. TWO PROMUS 2.5 X 23MM STENTS WERE IMPLANTED IN THE OBTUSE MARGINAL AT 12 ATMOSPHERES FOR EACH STENT. INTRAVASCULAR ULTRASOUND WAS PERFORMED, AND IT WAS CONFIRMED THAT THE STENTS WERE IMPLANTED IN GOOD CONDITION, AND THE PROCEDURE WAS COMPLETED. ON (B)(6) 2010, THE PATIENT EXPERIENCED CHEST PAIN AND CAME TO THE HOSPITAL. ANGIOGRAPHY WAS PERFORMED AND SUB-ACUTE THROMBOSIS WAS SUSPECTED. ASPIRATION WAS PERFORMED TO TREAT THE THROMBOSIS, AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PHYSICIAN COMMENTS: SINCE THE PATIENT HAD NOT ONLY POOR BLOOD FLOW, BUT ALSO SMALL VESSELS AND A DIFFUSE LESION, SUB-ACUTE THROMBOSIS MAY HAVE OCCURRED. THE PHYSICIAN KNEW THAT THE USE OF THE PROMUS ON A VESSEL OVER 2.5MM IN DIAMETER VESSEL WAS OFF-LABEL AND ALSO CONSIDERED THAT RESTENOSIS COULD OCCUR DUE TO THE SMALL VESSEL AND THE LONG LESION. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    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 0062961

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R