BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1895011 · Received November 5, 2010

    Report

    Report Number
    2024168-2010-02351
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    January 7, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ABBOTT VASCULAR-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURER, DESIGN, OR LABELING. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Additional Manufacturer Narrative · 1

    (B)(4). PROMUS PART, LOT, AND SERIAL NUMBERS WERE RECEIVED. SINCE IT WAS REPORTED THAT THE PROMUS BALLOON WAS INFLATED TO 20 ATMOSPHERES (ATM), WHICH IS ABOVE THE RATED BURST PRESSURE (RBP) OF 16 ATM, IT SHOULD BE NOTED THAT THE PROMUS INSTRUCTIONS FOR USE (IFU) STATES: DO NOT EXCEED RBP AS INDICATED ON PRODUCT LABEL. BALLOON PRESSURES SHOULD BE MONITORED DURING INFLATION. IT CANNOT BE DETERMINED WHETHER THE IFU DEVIATION CONTRIBUTED TO THE REPORTED PATIENT EFFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PT UNDERWENT STENTING WITH TWO XIENCE V STENTS TO TREAT RESTENOSIS OF A PROMUS STENT IMPLANTED IN THE HEAVILY CALCIFIED LEFT PROXIMAL CIRCUMFLEX ARTERY. THE PT WAS ADMITTED ON (B)(6) 2010 AND WAS DISCHARGED ON (B)(6) 2010. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE U.S.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MED WATCH FILED, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT BEGAN HAVING RETROSTERNAL CHEST PAIN 2 TO 3 DAYS PRIOR TO ADMISSION ON (B)(6) 2010. THE PATIENT HAD BEEN TAKING NITROGLYCERIN AT HOME FOR THE CHEST PAIN WHICH IMPROVED, BUT WAS WORSE ON (B)(6) 2010 WHEN HE PRESENTED TO THE EMERGENCY DEPARTMENT. THE CARDIAC ENZYMES REMAINED NORMAL THROUGH OUT THE HOSPITAL STAY, THE ECG SHOWED A PACED HEART RHYTHM, AND THE PATIENT'S VITAL SIGNS WERE WITHIN NORMAL LIMITS UPON PRESENTATION. ON (B)(6) 2010, THE PATIENT UNDERWENT A MYOCARDIAL PERFUSION STUDY THAT WAS NOTED TO BE SLIGHTLY WORSE THAN HIS PREVIOUS STRESS TEST WHICH WARRANTED A DIAGNOSTIC HEART CATHETERIZATION ON (B)(6) 2010 AND PERCUTANEOUS CORONARY INTERVENTION ON (B)(6) 2010. THE PROMUS STENT WAS INITIALLY IMPLANTED ON (B)(6) 2009 AT 20 ATMOSPHERES FOR 30 SECONDS BY DR. (B)(6). THE INDEX STUDY PROCEDURE ON (B)(6) 2010 WITH THE IMPLANTATION OF A XIENCE STENT WAS BY DR. (B)(6). THERE WAS NO ADVERSE PATIENT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-TEMECULA NA 8110461

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R VESSEL CLOSURE: ANGIO-SEAL