BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX?

    MDR report key: 3102908 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03333
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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 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

    (B)(4). IT WAS FURTHER REPORTED THAT THE STENT DISLODGED FROM THE BALLOON IN THE AREA OF THE VEIN GRAFT AND THE RIGHT CORONARY ARTERY. THE PHYSICIAN AS UNABLE TO RETRIEVE IT WITH A SECOND WIRE AND PULLED THE WIRES, STENT AND CATHETER BACK TO THE AREA OF THE RIGHT EXTERNAL ILIAC ARTERY WHERE IT GOT LODGED JUST ABOVE THE INGUINAL LIGAMENT. DECISION WAS MADE TO CUT THE WIRE AND SECURE THE WHOLE DEVICE FOR REMOVAL BY A THORACIC SURGEON, WHO REMOVED THE STENT, CORRECTED FROM THE STENT BEING SNARED OUT DURING THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT INCIDENT AND WAS DISCHARGED HOME.

    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 A VERY CALCIFIED AND TORTUOUS VEIN GRAFT. A 4.00MM X 24MM VERIFLEX STENT WAS UNABLE TO CROSS THE LESION. THE STENT WAS DISLODGED OFF THE BALLOON IN THE PROXIMAL PART OF THE VEIN GRAFT AND THE STENT WAS SNARED OUT. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY WITHOUT STENTING. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203955 VERIFLEX? STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893424400 14888986

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention