BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1772370 · Received July 23, 2010

    Report

    Report Number
    2024168-2010-01475
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 24, 2010
    Report Date
    June 29, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THROMBOSIS IS A KNOWN ADVERSE EVENT AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT 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. THE 2.75 X 8 MM PROMUS (PART 1009540-08B, LOT UNK), INDICATED IS BEING FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: ACUTE THROMBOSIS. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESIONS IN THE MID - DISTAL CIRCUMFLEX (CX). A NON-ABBOTT DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE MID CX (L1), THEN A 2.75 X 12 MM PROMUS STENT WAS IMPLANTED IN THE DISTAL CX (L2) AND A 2.75 X 8 MM PROMUS STENT WAS IMPLANTED IN THE MID CX (L3). THE PROCEDURE WAS COMPLETED UNEVENTFULLY. APPROX 2 HOURS POST-PROCEDURE, THE PT RETURNED TO THE CATH LAB WITH THE VESSEL TOTALLY OCCLUDED DUE TO IN STENT THROMBOSIS. A NON-ABBOTT BALLOON CATHETER WAS USED FOR SEVERAL DILATATIONS IN THE NON-ABBOTT DES (L1). THEN A NON-ABBOTT DES WAS IMPLANTED (L1), COMPLETING THE PROCEDURE. THERE WAS NO REPORTED TREATMENT OF THE PROMUS STENTS. THERE WAS NO REPORTED PT SEQUELA. NO ADDITIONAL INFO WAS PROVIDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 0011441

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other SHEATH: 6F TERUMO| STENT: 3.0 X 30 MM ENDEAVOR| GUIDE WIRE: BMW 190| INFLATION: INDEFLATOR W/ COPILOT| GUIDE CATH: MEDTRONIC 6F| 2.75 X 8 MM PROMUS (PART 1009540-08B, LOT UNK)| VESSEL CLOSURE: ST JUDE ANGIOSEAL