BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2090383 · Received May 16, 2011

    Report

    Report Number
    2024168-2011-03503
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    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. GUIDE WIRE: KINETIX. SHEATH: TERUMO 6FR. STENT: 3.5X28 PROMUS. IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. PERFORATION AND PAIN ARE KNOWN ADVERSE EVENTS LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. IT WAS REPORTED THAT THE 3.5 X 28MM PROMUS STENT WAS DEPLOYED AT 18 ATMOSPHERES, WHICH IS ABOVE THE RATED BURST PRESSURE. IT SHOULD BE NOTED THAT THE PROMUS IFU STATES: DO NOT EXCEED RATED BURST PRESSURE AS INDICATED ON PRODUCT LABEL. BALLOON PRESSURES SHOULD BE MONITORED DURING INFLATION. USE OF PRESSURES HIGHER THAN SPECIFIED ON PRODUCT LABEL MAY RESULT IN A RUPTURED BALLOON WITH POSSIBLE INTIMAL DAMAGE AND DISSECTION. IN THIS CASE, IS POSSIBLE THAT THE REPORTED IFU DEVIATION CONTRIBUTED TO THE REPORTED PERFORATION THAT OCCURRED DURING THE INDEX PROCEDURE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE RIGHT CORONARY ARTERY, PRE-DILATATION WAS PERFORMED AND A 3.5X28 RX PROMUS STENT WAS DEPLOYED AT 16 ATMOSPHERES (ATMS). A SECOND 3.5X28 RX PROMUS STENT WAS DEPLOYED AT 18 ATMS OVERLAPPING THE PREVIOUSLY DEPLOYED STENT. AFTER DEPLOYMENT OF THE SECOND STENT, A PERFORATION WAS NOTED. A 3.5X19 GRAFTMASTER OTW STENT WAS DEPLOYED FOR TREATMENT OF THE PERFORATION. THE PATIENT COMPLAINED OF BACK PAIN. A 3.5X15 RX PROMUS STENT WAS DEPLOYED AT 20 ATMS TO SUCCESSFULLY TREAT THE LESION. POST DILATATION WAS PERFORMED SUCCESSFULLY USING A NON-ABBOTT BALLOON. POST PROCEDURE, THE PATIENT'S BACK PAIN HAD DECREASED AND THE PATIENT WAS REPORTED AS DOING FINE. THOUGH REQUESTED, 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-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention