BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3002271 · Received March 13, 2013

    Report

    Report Number
    2134265-2013-01652
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, CHEST PAIN OCCURRED. ON (B)(6) 2013 - THE PATIENT PRESENTED WITH UNSTABLE ANGINA. TARGET LESION # 1 WAS AN OSTIAL LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH 90% IN-STENT RESTENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM WHICH WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 X 28 MM PROMUS ELEMENT PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION # 2 WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 80% IN-STENT RESTENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM WHICH WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.00 X 16 MM PROMUS ELEMENT PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT THEN EXPERIENCED CHEST PAIN AND ELECTROCARDIOGRAM (ECG) CHANGES. A SUBTOTAL OCCLUSION DUE TO A DISTAL LAD EMBOLISM WAS TREATED WITH BALLOON ANGIOPLASTY, USING A 2.5 X 15 MM APEX BALLOON. THE PHYSICIAN ADMINISTERED 50 MCG OF FENTANYL FOR THE CHEST PAIN AND THE EVENT WAS CONSIDERED RESOLVED. THE PATIENT WAS DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104632 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416300 15772928

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention