BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (TM)

    MDR report key: 2162397 · Received July 14, 2011

    Report

    Report Number
    2134265-2011-02861
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION OF THE DELIVEY DEVICE IDENTIFIED THAT THE STENT WAS DETACHED FROM THE BALLOON AND WAS NOT RETURNED FOR ANALYSIS. AN EXAMINATION OF THE BALLOON IDENTIFIED A CLEAR IMPRESSION OF WHERE THE STENT HAD BEEN CRIMPED INITIALLY. THE BALLOON DID NOT APPEAR TO HAVE BEEN SUBJECTED TO ANY POSITIVE PRESSURE. NO ISSUES EXISTED WITH THE PROFILE OF THE TIP SECTION OF THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE PROCEDURE WAS TREATING IN-STENT RESTENOSIS OF AN UNSPECIFIED STENT LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). ACCORDING TO THE PHYSICIAN, IT WAS HARD TO ADVANCE THE 4.0X32MM VERIFLEX TO THE TARGET LESION. DURING ATTEMPTS TO POSITION THE STENT, A NON BSC GUIDE CATHETER DISPOSITIONED IN THE AORTA ARTERY AND AN ATTEMPT WAS MADE TO REPOSITION THE GUIDE CATHETER. AT THE SAME TIME, THE PHYSICIAN FELT THE STENT DELIVERY SYSTEM MAY HAVE BEEN TRAPPED IN THE LESION AND DURING THE REPOSITIONING OF THE GUIDE CATHETER GOT PULLED BACK, DISLODGING THE STENT. THE VERIFLEX STENT WAS IMPLANTED IN THE PROXIMAL RCA WHERE IT DISLODGED. THE TARGET LESION WAS TREATED WITH A 4.0X24MM NON BSC STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS RECOVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE PROCEDURE WAS TREATING IN-STENT RESTENOSIS OF AN UNSPECIFIED STENT LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). ACCORDING TO THE PHYSICIAN, IT WAS HARD TO ADVANCE THE 4.0X32MM VERIFLEX TO THE TARGET LESION. DURING ATTEMPTS TO POSITION THE STENT, A NON BSC GUIDE CATHETER DISPOSITIONED IN THE AORTA ARTERY AND AN ATTEMPT WAS MADE TO REPOSITION THE GUIDE CATHETER. AT THE SAME TIME, THE PHYSICIAN FELT THE STENT DELIVERY SYSTEM MAY HAVE BEEN TRAPPED IN THE LESION AND DURING THE REPOSITIONING OF THE GUIDE CATHETER GOT PULLED BACK, DISLODGING THE STENT. THE VERIFLEX STENT WAS IMPLANTED IN THE PROXIMAL RCA WHERE IT DISLODGED. THE TARGET LESION WAS TREATED WITH A 4.0X24MM NON BSC STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (TM) STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893432400 0012831247

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TERUMO SHEATH| HEARTRAIL JR4 6F GUIDE CATHETER| ENCORE 26 INFLATION DEVICE| PROFIT AL1 SH GUIDE CATHETER