BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2023666 · Received March 18, 2011

    Report

    Report Number
    2024168-2011-01811
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    December 14, 2010
    Report Date
    February 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA, ISCHEMIA, THROMBOSIS AND RESTENOSIS, AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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. THE OTHER PROMUS STENTS REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. THE ESTIMATED DATE OF THE EVENT WHICH WAS REPORTED AS OCCURRING (B)(6) 2010. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF ANGINA, ISCHEMIA AND THROMBOSIS, AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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 OR DESIGN. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY NINE MONTHS POST MULTIPLE OVERLAPPING PROMUS STENTING WITH ONE 3.0 X 15 STENT IN THE OSTIAL RIGHT CORONARY ARTERY, ONE 3.0 X 28 STENT IN THE MID RIGHT CORONARY ARTERY (MRCA), ONE 2.75 X 18 STENT IN THE MID TO DISTAL RIGHT CORONARY ARTERY AND ONE 3.0 X 12 STENT IN THE DISTAL RIGHT CORONARY ARTERY, THE PATIENT EXPERIENCED CHEST PAIN AND WAS FOUND TO HAVE A POSITIVE STRESS TEST DEMONSTRATING MYOCARDIAL ISCHEMIA. ON (B)(6) 2010, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION FOR STENT THROMBOSIS IN THE OSTIAL, PROXIMAL AND MRCA STENTS. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010 AND THE PATIENT WAS DISCHARGED. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE FINAL MEDWATCH REPORT FILED ON (B)(4) 2013, ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATES THAT THE DATE OF OCCURRENCE WAS (B)(6) 2010. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATES THAT APPROXIMATELY 9 MONTHS POST STENTING PROCEDURE, THE PATIENT HAD ELEVATED CARDIAC ENZYMES. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION TO TREAT IN-STENT RESTENOSIS AND STENT THROMBOSIS. 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 9120741

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R PROMUS RX 3.0 X 12 MM, 3.0 X 28 MM, 2.75 X 18 MM