BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3203052 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04645
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING A POST PERCUTANEOUS CORONARY INTERVENTION (PCI), CHEST PAIN AND TARGET VESSEL REVASCULARIZATION OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AN WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 75% STENOSED TARGET LESION # 1 WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY EXTENDING TO MID LAD WITH A LESION LENGTH OF 10MM LONG AND REFERENCE VESSEL DIAMETER OF 3MM. AFTER PRE-DILATATION, A 3.50 MM X 20 MM PROMUS ELEMENT PLUS WAS ADVANCED AND THE STENT WAS DEPLOYED ON THE TARGET LESION. AFTER POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. THE 90% STENOSED TARGET LESION # 2 WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH A LESION LENGTH OF 5MM LONG AND REFERENCE VESSEL DIAMETER OF 4.5MM. AFTER PRE-DILATATION, A 4.00 MM X 16 MM PROMUS ELEMENT PLUS WAS ADVANCED AND THE STENT WAS DEPLOYED ON THE TARGET LESION. AFTER POST-DILATATION, RESIDUAL STENOSIS WAS 0%. ONE-DAY POST-PROCEDURE, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE PATIENT PRESENTED WITH CARDIAC CHEST PAIN AND WAS HOSPITALIZED ON THE SAME DAY. CARDIAC CATHETERIZATION WAS RECOMMENDED. AFTER ONE DAY, PCI WAS PERFORMED TO TREAT IN-STENT RESTENOSIS OF THE STUDY STENT IN THE PROXIMAL LAD. THE EVENT WAS RESOLVED ONE DAY LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301113 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911420350 15221029

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R