BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1923376 · Received December 13, 2010

    Report

    Report Number
    2024168-2010-02698
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    March 23, 2009
    Report Date
    November 19, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE DEVICE BECAUSE IT WAS NOT RETURNED FOR EVALUATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. DISSECTION IS A KNOWN ADVERSE EVENT AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU). 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE PROXIMAL RIGHT CORONARY ARTERY A 3.0X28 RX PROMUS STENT WAS IMPLANTED. A GRADE F DISSECTION OCCURRED DISTAL TO THE TARGET LESION. THE DISSECTION WAS TREATED WITH THE PLACEMENT OF TWO ADDITIONAL RX PROMUS STENTS, A 3.0 X 12 MM AND A 3.0 X 28 MM. FOLLOWING POST-DILATATION, THERE WAS 0% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED ON (B)(6) 2009 WITH ASPIRIN AND CLOPIDOGREL PRESCRIBED. PER PHYSICIAN, THE RELATIONSHIP OF THE ADVERSE EVENT TO THE INDEX PROCEDURE IS HIGHLY PROBABLE. NO ADDITIONAL INFORMATION HAS BEEN 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 8100761

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention RX PROMUS STENTS 3.0X12 & 3.0X28