BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2761080 · Received September 26, 2012

    Report

    Report Number
    2134265-2012-05767
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    August 28, 2012
    Report Date
    August 28, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2012- 05766. IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, STENT APPOSITION AND THROMBOSIS WERE REPORTED. THE PATIENT PRESENTED IN CARDIOGENIC SHOCK FOR AN ACUTE INFERIOR MYOCARDIAL INFARCTION WITH MULTIPLE VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION ARRESTS. THE PATIENT WAS INTUBATED IN THE FIELD. USING THE RIGHT FEMORAL APPROACH, THE PROCEDURE TREATED THE RIGHT CORONARY ARTERY (RCA). A 2.5X20MM PROMUS ELEMENT PLUS STENT WAS DEPLOYED AND POST DILATED. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED AND THE PATIENT WAS BROUGHT TO THE FLOOR. SIX DAYS LATER THE PATIENT WAS BROUGHT BACK FOR AN ELECTIVE PROCEDURE IN THE LEFT CIRCUMFLEX (LCX) ARTERY AND A 2.25X16MM PROMUS ELEMENT PLUS STENT WAS IMPLANTED. AT THIS TIME "THEY ALSO DID A RE-SHOOT OF THE RCA THAT WAS PREVIOUSLY STENTED". ON DAY 7, THE PATIENT EXPERIENCED CHEST PAIN AND WAS TAKEN BACK TO THE CATH LAB WHICH REVEALED "THE RCA STENT HAD CLOTTED OFF". THEY ASPIRATED THE CLOT AND POST DILATED THEN PLACED A 3.0X12MM PROMUS ELEMENT PLUS STENT PROXIMAL TO THE PREVIOUS 2.5X20MM PROMUS ELEMENT PLUST STENT IN THE RCA. ON DAY 13, THE PATIENT RETURNED WITH STENT THROMBOSIS IN THE LCX ARTERY AND THE LESION WAS ASPIRATED AND POST DILATED WITH A 2.75X12MM AND 3.0X8.0MM QUANTUM APEX BALLOON. POST IVUS SHOWED A SLIGHTLY REDUCED APPOSITION OF THE DISTAL STENT. THE PATIENT WAS TAKING PLAVIX TO START WITH AND THEN POST THE RCA THROMBOSIS WAS SWITCHED TO EFFIENT. ON DAY 18, THE PATIENT HAD AN ADDITIONAL THROMBUS EVENT IN THE LCX ARTERY AND TREATMENT UTILIZED AN ASPIRATION CATHETER AND POBA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911416220 14659168

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention