BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1211585 · Received October 23, 2008

    Report

    Report Number
    2024168-2008-01007
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 15, 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 - IT WAS REPORTED THAT A PERFORATION OCCURRED DURING A DIRECT STENTING. THE PROMUS IFU STATES, "PRE-DILATE THE LESION WITH A PTCA CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED." PERFORATION, AS LISTED IN THE PROMUS IFU, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. PERFORATION CAN BE INFLUENCED BY SEVERAL FACTOR, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, OR PROCEDURAL TECHNIQUE. AS THERE WAS NO REPORTED DEVICE MALFUNCTION, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY PROBLEM. A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PT EFFECTS, 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 MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MID LAD. AFTER DIRECT STENTING WITH THE 2.5 X 12 MM PROMUS STENT, A PERFORATION WAS OBSERVED UNDER ANGIOGRAPHY. THE STENT DELIVERY SYSTEM (SDS) BALLOON WAS USED TO SEAL UP THE PERFORATION. THE PATIENT IS FINE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS IT 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 8011441

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention