BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1576672 · Received January 11, 2010

    Report

    Report Number
    2024168-2010-00054
    Event Type
    Injury
    Date Received
    January 11, 2010
    Date of Event
    December 11, 2009
    Report Date
    December 17, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. IN THIS CASE, THE PATIENT'S ANATOMICAL INFORMATION WAS NOT PROVIDED; HOWEVER, BASED ON THE REPORTED INFORMATION THAT STENT DISLODGEMENT OCCURRED WITH TWO PROMUS STENTS FROM DIFFERENT MANUFACTURING LOT NUMBERS, IT IS POSSIBLE THAT THE PATIENT'S ANATOMY AND/OR LESION MORPHOLOGY MAY HAVE CONTRIBUTED TO THE REPORTED DISLODGEMENTS. OVERALL, A CONCLUSIVE CAUSE FOR THE STENT DISLODGEMENTS COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT RELATED QUALITY DEFICIENCY. THE FIRST PROMUS (PART 1009539-15B, LOT 9071641), HAS BEEN FILED UNDER MFR#2024168-2010-00052.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION/PERMANENT DAMAGE. REPORTING RATIONALE: DISLODGED STENT COMPRESSED IN AN UNINTENDED SITE. DEVICE ISSUE: STENT DISLODGMENT. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CX. THE 2.5 X 15 PROMUS STENT DISLODGED IN THE CX AND WAS RETRIEVED WITH A SNARE. THE 2.5 X 18 PROMUS STENT DISLODGED IN THE CX AND WAS CRUSHED AGAINST THE VESSEL WALL WITH A 4.0 X 20 PROMUS STENT. A 3.0 X 23 PROMUS STENT WAS SUCCESSFULLY IMPLANTED IN THE TARGET LESION. THERE WERE NO PATIENT COMPLICATIONS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE ANOTHER MFR DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 9062361

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention LOT 9071641),| STENT: 2.5 X 15 MM PROMUS (PART 1009539-15B,| 3.0 X 23 MM PROMUS