BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2961528 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00551
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED PRODUCT REVEALED ONLY THE STENT WAS RETURNED. VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT A PORTION OF THE STENT WAS RETURNED BUNCHED INTO A BALL AND COVERED IN BLOOD. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE CIRCUMFLEX ARTERY (CX). A 3.0X8.0MM PROMUS ELEMENT PLUS DRUG-ELUTING STENT SYSTEM WAS ADVANCED AND THE STENT WAS DEPLOYED FURTHER DISTAL IN THE LESION THAN THE PHYSICIAN INTENDED. A SECOND 3.0X8.0MM PROMUS ELEMENT PLUS DRUG-ELUTING STENT SYSTEM WAS THEN ADVANCED. WHILE POSITIONING, THE PHYSICIAN PULLED BACK ON THE DELIVERY SYSTEM AND THE STENT CAUGHT ON THE FIRST IMPLANTED STENT. THE SECOND STENT DISLODGED FROM THE DELIVERY SYSTEM, BUT REMAINED ON THE GUIDE WIRE. A LARGER SHEATH WAS PLACED AND AFTER A SIGNIFICANT AMOUNT OF TIME, THE STENT WAS ABLE TO BE SNARED SUCCESSFULLY FROM THE PATIENT. THE PROCEDURE WAS NOT COMPLETED. NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE CIRCUMFLEX ARTERY (CX). A 3.0X8.0MM PROMUS ELEMENT PLUS DRUG-ELUTING STENT SYSTEM WAS ADVANCED AND THE STENT WAS DEPLOYED FURTHER DISTAL IN THE LESION THAN THE PHYSICIAN INTENDED. A SECOND 3.0X8.0MM PROMUS ELEMENT PLUS DRUG-ELUTING STENT SYSTEM WAS THEN ADVANCED. WHILE POSITIONING, THE PHYSICIAN PULLED BACK ON THE DELIVERY SYSTEM AND THE STENT CAUGHT ON THE FIRST IMPLANTED STENT. THE SECOND STENT DISLODGED FROM THE DELIVERY SYSTEM, BUT REMAINED ON THE GUIDE WIRE. A LARGER SHEATH WAS PLACED AND AFTER A SIGNIFICANT AMOUNT OF TIME, THE STENT WAS ABLE TO BE SNARED SUCCESSFULLY FROM THE PATIENT. THE PROCEDURE WAS NOT COMPLETED. NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66160 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911608300 15490016

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention