BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3222429 · Received July 12, 2013

    Report

    Report Number
    2134265-2013-04817
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. 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. 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

    SAME CASE AS: 2134265-2013-04816. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS FIRST DIAGONAL OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). PRE-DILATION AT 11 ATMOSPHERES FOR 30 SECONDS WITH AN UNKNOWN BALLOON CATHETER WAS PERFORMED TWICE. A 3.00MM X 20MM PROMUS ELEMENT PLUS STENT WAS IMPLANTED, THEN AN ATLANTIS SR PRO² IMAGING CATHETER WAS USED TO VISUALIZE THE LESION POST-STENTING. DURING WITHDRAWAL, THE GUIDE WIRE EXIT PORT OF THE IMAGING CATHETER GOT STUCK WITH THE STENT, AND THE STENT GOT DEFORMED AND SHORTENED. THE PHYSICIAN MANIPULATED THE ATLANTIS AND CONTINUED WITHDRAWING. SUBSEQUENTLY, THE IMAGING CATHETER GOT STUCK ON A NON-BSC GUIDE WIRE. AS A RESULT, ATLANTIS WAS REMOVED TOGETHER WITH THE GUIDE WIRE. A 3.00MM X 38MM PROMUS ELEMENT STENT WAS DEPLOYED TO TREAT THE DAMAGED PORTION OF THE PREVIOUSLY PLACED 3.00X20MM PROMUS ELEMENT PLUS STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER F/G ATLANTIS SR PRO2. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322022 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918420300 15937749

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ATLANTIS SR PRO² IMAGING CATHETER| INTRODUCER SHEATH:6FR TRA| GUIDEWIRE:RUNTHROUGH