BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1828377 · Received September 3, 2010

    Report

    Report Number
    3004742046-2010-00402
    Event Type
    Injury
    Date Received
    September 3, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 12, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. A REVIEW OF THE DEVICE LOT HISTORY RECORD IS FORTHCOMING. THE XACT CAROTID STENT SYSTEM (PART # 82090-01, LOT# 0052061) IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    DEVICE ISSUE: DIFFICULTY REMOVING STENT DELIVERY SYSTEM/FILTER. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: SURGICAL EXCISION OF DEVICES. IT WAS REPORTED VIA TRIAL THAT AFTER THE XACT STENT WAS FULLY DEPLOYED IN THE RIGHT INTERNAL CAROTID ARTERY. THE DISTAL NOSE CONE OF THE STENT DELIVERY SYSTEM (SDS) BECAME TRAPPED IN THE STENT. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE SDS WITH TRACTION. ON THE FINAL ATTEMPT, THE SDS AVULSED FROM THE DISTAL END OF THE CATHETER WHICH REMAINED TRAPPED IN THE STENT AT THE SITE OF THE INDEX LESION. ATTEMPTS MADE TO SNARE THIS WERE UNSUCCESSFUL. MULTIPLE WIRES WERE USED TO TRY AND PASS THROUGH THE KINKED STENT IN ORDER TO ATTEMPT EXPANDING IT WITH A BALLOON TO ALLOW REMOVAL OF THE EQUIPMENT. THIS TOO WAS UNSUCCESSFUL. THE PATIENT REMAINED COMPLETELY ASYMPTOMATIC. FLUSH INJECTIONS DEMONSTRATED NO ANTEGRADE FLOW PAST THE SITE OF THE INDEX LESION WHERE THE STENT WAS KINKED; THEREFORE, EMERGENT SURGICAL EXCISION OF THE SDS AND EMBOLIC PROTECTION DEVICE AND ENDARTERECTOMY WERE PERFORMED. IT WAS CONFIRMED SURGICALLY THAT THE ETIOLOGY DID APPEAR TO BE SHIFTING OF THE PLAQUE UPON DEPLOYMENT OF THE STENT, RESULTING IN A TIGHT KINK, TRAPPING BOTH THE SDS AND THE EMBOLIC PROTECTION DEVICE. THE PATIENT'S OPERATIVE COURSE WAS UNEVENTFUL. HOSPITALIZATION WAS PROLONGED AND THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2010. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9112151

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R PART # 82090-01, LOT # 0052061| STENT: XACT CAROTID STENT SYSTEM