BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1210254 · Received October 21, 2008

    Report

    Report Number
    2024168-2008-00984
    Event Type
    Injury
    Date Received
    October 21, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 24, 2008
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION AT THE TIME OF THE STENT IMPLANT. IT WAS REPORTED THAT THE LESION WAS NOT PRE-DILATED PRIOR TO IMPLANT OF THE 3.0 X 15 MM PROMUS STENT. PERFORATION, AS LISTED IN THE PROMUS IFU, IS A KNOWN RISK ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. IT SHOULD BE NOTED THAT THE PROMUS IFU STATES, "PRE-DILATE THE LESION WITH A PTCA CATHETER." IT IS POSSIBLE THAT THE PERFORATION IS RELATED TO THE DIRECT STENTING TECHNIQUE. HOWEVER, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PT EFFECT, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: PERFORATION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE ISSUE HAS BEEN REPORTED. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MID CX. AFTER DIRECT STENTING WITH THE 3.0 X 15 MM PROMUS STENT, A PERFORATION WAS OBSERVED UNDER ANGIOGRAPHY. A 3.5 X 12 MM GRAFTMASTER STENT WAS USED TO SEAL THE PERFORATION. THE PT IS REPORTED TO BE FINE. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention