BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3013042 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01825
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A 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 BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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, VESSEL DISSECTION OCCURRED. (B)(6) 2012 - THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND MYOCARDIAL INFARCTION. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE RAMUS WITH 100% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM WHICH WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 16 MM PROMUS ELEMENT PLUS STENT, WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. (B)(6) 2013 - THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A PLANNED PCI. TWO LESIONS WERE BEING TREATED. THE 80% STENOSED, DE NOVO TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM WHICH WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.75 X 28 MM PROMUS ELEMENT PLUS STENT. FOLLOWING POST-DILATATION WITH 2.0 X 12 MM UNKNOWN BSC BALLOON A GRADE A DISSECTION WAS NOTED AND RESIDUAL STENOSIS WAS 0%. THE SECOND TARGET LESION WAS LOCATED IN THE MID LAD AND WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.50 X 12 MM PROMUS ELEMENT PLUS STENT. FOLLOWING WHICH A MID LAD DISSECTION WAS NOTED AND WAS TREATED WITH THE PLACEMENT OF AN ADDITIONAL UNSPECIFIED STENT. POST-DILATATION WAS PERFORMED AND TIMI 3 FLOW WAS NOTED. THE EVENT WAS CONSIDERED AS RESOLVED AND THE PATIENT WAS DISCHARGED THE NEXT DAY.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THERE WERE TWO DISSECTIONS THAT TOOK PLACE DURING THE (B)(6) 2013 PROCEDURE. ONE IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND ONE IN THE MID LAD WHICH WAS TREATED WITH AN UNSPECIFIED STENT. AFTER FURTHER REVIEW OF THE ADDITIONAL INFORMATION RECEIVED, ONLY THE PROXIMAL LAD DISSECTION OCCURRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116626 PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK717

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention