BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 4210766 · Received October 29, 2014

    Report

    Report Number
    2134265-2014-06711
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    August 19, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. IN (B)(6) 2014, CLINICAL ASSESSMENT IDENTIFIED PATIENT¿S QUALIFYING CONDITIONS AS UNSTABLE ANGINA AS WELL AS SILENT ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH REVEALED 4 LESIONS. TARGET LESION#1 WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) WITH 90% STENOSIS, A LENGTH OF 28 MM, AND A REFERENCE VESSEL DIAMETER OF 3.0 MM. TARGET LESION#1 WAS TREATED WITH PRE-DILATATION, PLACEMENT OF A 3.00 X 28 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. TARGET LESION#2 WAS LOCATED IN THE PROXIMAL LCX WITH 90% STENOSIS, A LENGTH OF 24 MM, AND A REFERENCE VESSEL DIAMETER OF 3.0 MM. TARGET LESION#2 WAS TREATED WITH PRE-DILATATION, PLACEMENT OF A 3.00 X 24 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. TARGET LESION#3 WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS, A LENGTH OF 12 MM, AND A REFERENCE VESSEL DIAMETER OF 4.0 MM. TARGET LESION#3 WAS TREATED WITH DIRECT PLACEMENT OF A 4.00 X 12 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. TARGET LESION#4 WAS LOCATED IN THE PROXIMAL RCA WITH 90% STENOSIS, A LENGTH OF 16 MM, AND A REFERENCE VESSEL DIAMETER OF 4.0 MM. A DISSECTION WAS NOTICED DURING THE INDEX PROCEDURE IN THE TARGET LESION#4 PROXIMAL RCA WHICH WAS TREATED WITH DIRECT PLACEMENT OF A 4.00 X 16 MM PROMUS ELEMENT ¿ DRUG-ELUTING STENT, FOLLOWING STUDY STENT PLACEMENT A WIDE TEAR APPEARED IN THE PROXIMAL RCA. THE GRADE C DISSECTION IN THE PROXIMAL RCA WAS SUBSEQUENTLY TREATED USING A NON-BSC STENT AS BAILOUT, FOLLOWING INTERVENTION THE PATIENT RECOVERED AND THE EVENT RESOLVED. THE EVENT LED TO THE PROLONGATION OF INITIAL HOSPITALIZATION AND THE SUBJECT WAS DISCHARGED 4 DAYS POST INDEX PROCEDURE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT TARGET LESION#1 WAS LOCATED IN THE PROXIMAL LCX EXTENDING INTO THE DISTAL LCX WITH 90% STENOSIS, A LENGTH OF 50 MM, AND A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE TARGET LESION#1 WAS TREATED WITH PRE-DILATATION, PLACEMENT OF 3.00 X 28 MM AND 3.00 X 24 MM PROMUS ELEMENT STUDY STENTS WITH 0% RESIDUAL STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693830 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316400 16015005

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R