BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS? LD VASCULAR

    MDR report key: 4143533 · Received October 6, 2014

    Report

    Report Number
    2134265-2014-05962
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RECEIVED WAS THE SHEATH WITH THE DETACHED STENT PARTIALLY INSERTED INTO THE SHEATH. THE DISTAL END OF THE STENT , PROTRUDING FROM THE SHEATH WAS DAMAGED WITH STENT STRUTS MISALIGNED. NO DAMAGE WAS NOTED ALONG THE SHEATH. THE STENT WAS REMOVED FROM THE SHEATH. THE STENT DID NOT APPEAR TO HAVE BEEN DEPLOYED. NO OTHER DAMAGE WAS NOTED ALONG THE PROXIMAL SECTION OF THE STENT WHICH HAD BEEN INSERTED INSIDE THE SHEATH. 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).

    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 STENT DISLODGEMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT EXTERNAL ILIAC ARTERY. A 8X80MM EPIC STENT WAS DEPLOYED IN THE EXTERNAL ILIAC ARTERY. A 7.0X60X75CM EXPRESS LD VASCULAR STENT WAS SELECTED TO TREAT THE LESION. THE PHYSICIAN TRIED TO DEPLOY THIS DEVICE IN THE PROXIMAL SIDE OF THE EXTERNAL ILIAC ARTERY, OVERLAPPING THE PREVIOUSLY IMPLANTED STENT; HOWEVER THIS DEVICE CAME INTO CONTACT WITH THE STENT STRUT OF THE PREVIOUSLY IMPLANTED STENT. THE PHYSICIAN MOVED THE DEVICE BACKWARD AND FORWARD. WHE THE DEVICE WAS MOVED BACK INTO AN UNSPECIFIED SHEATH, IT WAS NOTED THAT THE STENT WAS DISLODGED. THE DISLODGED STENT AND THE SHEATH WERE REMOVED TOGETHER FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT EXTERNAL ILIAC ARTERY. A 8X80MM EPIC STENT WAS DEPLOYED IN THE EXTERNAL ILIAC ARTERY. A 7.0X60X75CM EXPRESS¿ LD VASCULAR STENT WAS SELECTED TO TREAT THE LESION. THE PHYSICIAN TRIED TO DEPLOY THIS DEVICE IN THE PROXIMAL SIDE OF THE EXTERNAL ILIAC ARTERY, OVERLAPPING THE PREVIOUSLY IMPLANTED STENT; HOWEVER, THIS DEVICE CAME INTO CONTACT WITH THE STENT STRUT OF THE PREVIOUSLY IMPLANTED STENT. THE PHYSICIAN MOVED THE DEVICE BACKWARD AND FORWARD. WHEN THE DEVICE WAS MOVED BACK INTO AN UNSPECIFIED SHEATH, IT WAS NOTED THAT THE STENT WAS DISLODGED. THE DISLODGED STENT AND THE SHEATH WERE REMOVED TOGETHER FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623279 EXPRESS? LD VASCULAR CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162760750 16871122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INTRODUCER SHEATH: 6FR SHEATH (ZEON)| GUIDE WIRE: 035 X 260 CM RADIFOCUS (TERUMO)| BALLOON CATHETER: STERLING 4MM X 40MM