BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERLING MONORAIL

    MDR report key: 836412 · Received April 4, 2007

    Report

    Report Number
    6000093-2007-00706
    Event Type
    Injury
    Date Received
    April 4, 2007
    Date of Event
    March 7, 2007
    Report Date
    March 7, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    SAME CASE AS MFR'S REPORT# 2954755-2007-00026 AND 6000093-2007-00705. IT WAS REPORTED THAT DURING A CAROTID ARTERY ANGIOPLASTY / STENTING TREATMENT PROCEDURE, POST-DILATATION, STENT MIGRATION, AND DEVICE REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE VESSEL DIAMETER WAS 7-8MM AND WAS NOT PREDILATED. THE CUSTOMER STATED THAT, "THE PT HAD A HIGHLY CALCIFIED, TORTUOUS INTERNAL CAROTID ARTERY CALCIFICATION. THE LESION WAS SUCCESSFULLY CROSSED WITH THE FILTERWIRE EZ AND FILTER WAS DEPLOYED. PHYSICIAN OPTED NOT TO PRE-DILATE THE LESION. THE NEXSTENT WAS POSITIONED ACROSS THE LESION AND DEPLOYED SUCCESSFULLY. A STERLING PTA BALLOON (5X20) WAS SELECTED TO POST-DILATE THE STENT. AS THE PHYSICIAN WAS CROSSING THE EDGE OF THE STENT, THE BALLOON CAUGHT ON THE EDGE OF THE STENT AND PUSHED THE STENT UP ABOUT 10MM DISTALLY. EVENTUALLY, THE PHYSICIAN WAS ABLE TO POST-DILATE THE STENT IN PLACE. THE BALLOON CATHETER WAS REMOVED, AND THE FILTERWIRE EZ RETRIEVAL SHEATH WAS LOADED OVER THE WIRE AND ADVANCED UP TO THE STENT. UNFORTUNATELY, THE RETRIEVAL SHEATH WOULD NOT CROSS THE STENT AND WAS REMOVED. A BENT-TIP RETRIEVAL SHEATH WAS THEN UTILIZED TO TRY AND CROSS THE STENT, BUT ALSO WAS UNSUCCESSFUL. AFTER SEVERAL ATTEMPTS, A [REDACTED] RETRIEVAL SHEATH WAS USED TO SUCCESSFULLY CROSS THE NEXSTENT AND RECAPTURE THE FILTERWIRE EZ AND WAS REMOVED. THE PT DID EXPERIENCE SOME VESSEL SPASM IN THE INTERNAL CAROTID AND HAD SOME TRANSIENT ISCHEMIA." CURRENT PT STATUS WAS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING MONORAIL DQY CATHETER, PERCUTANEOUS, SAPHENOUS VEIN BYPASS GRAFT, TEM DQY BOSTON SCIENTIFIC CORP. NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention GUIDANT RETRIEVAL SHEATH