BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1937242 · Received December 23, 2010

    Report

    Report Number
    3004742046-2010-00644
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 9, 2010
    Manufacturer
    AV-TEMECULA-VS
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: TERUMO GLIDEWIRE. STENT: RX ACCULINK ((B)(4), LOT # 0010551) OTHER: HEPARIN EMBOLIC PROTECTION: EMBOSHIELD NAV 6 ((B)(4), LOT # 0101252) THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS REPORTED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). MIGRATION OF THE FILTER CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, DEVICE PLACEMENT TECHNIQUE, ACCESSORY DEVICE SUPPORT, AND INSUFFICIENT LANDING ZONE FOR THE FILTER BASKET. THE EMBOSHIELD NAV6 INSTRUCTION FOR USE PROVIDES THE FOLLOWING PRECAUTION: MAINTAIN PROPER GUIDING CATHETER / SHEATH SUPPORT IN THE COMMON CAROTID ARTERY THROUGHOUT THE PROCEDURE. BASED ON THE CASE DESCRIPTION, IT APPEARS THAT THE FILTER MIGRATION WAS LIKELY RELATED TO THE REPORTED PROLAPSE OF THE SHEATH DOWN INTO THE AORTA, AT WHICH TIME IT WAS REPORTED THAT THE EPD MIGRATED UPWARD AND WAS PULLED BACK INTO POSITION. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT. OVERALL, THE REPORTED FILTER MIGRATION APPEARS TO BE RELATED TO CASE CIRCUMSTANCES AND THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE EMBOSHIELD EMBOLIC PROTECTION DEVICE (EPD) WAS POSITIONED IN THE LEFT INTERNAL CAROTID ARTERY (LICA) WITHOUT DIFFICULTY AND PRE-DILATATION WAS DONE. THE SHEATH PROLAPSED DOWN INTO THE AORTA AND WAS PUSHED BACK INTO POSITION. DURING THIS TIME THE EPD MIGRATED UPWARD AND WAS PULLED BACK INTO POSITION. AN RX ACCULINK STENT DELIVERY SYSTEM (SDS) COULD NOT BE ADVANCED THROUGH THE SHEATH. THE SDS AND THE EPD WERE EASILY REMOVED, USING THE FILTER RETRIEVAL CATHETER. AFTER REMOVAL IT WAS NOTICED THAT THE GLIDEWIRE WIRE HAD COILED ON ITSELF IN THE SHEATH PREVENTING THE SDS FROM ADVANCING. ANOTHER EMBOSHIELD NAV 6 WAS INSERTED AND STENT IMPLANTATION WAS PERFORMED. ADDITIONALLY, BEFORE THE FIRST EPD WAS INSERTED THE PATIENT STARTED TO EXHIBIT SLURRED SPEECH. DURING THE PROCEDURE HIS SPEECH WORSENED, HE WAS UNCOOPERATIVE, AND WAS MOVING. REPORTEDLY THE PATIENT'S MOVEMENT DID NOT CONTRIBUTE TO THE SHEATH PROLAPSE AND FILTER MIGRATION. POST PROCEDURE THE PATIENT WAS INCREASINGLY AGITATED, UNCOOPERATIVE, BELLIGERENT AND COMBATIVE. FOUR POINT RESTRAINTS WERE USED TO CONTROL MOVEMENT AND MAINTAIN ACCESS SITE STABILITY. CT SCAN OF THE HEAD SHOWED NO ACUTE PROCESS. AFTER SPEAKING WITH THE FAMILY IT WAS LEARNED THAT THE PATIENT HAD SIGNIFICANT DAILY ALCOHOL CONSUMPTION THAT ABRUPTLY STOPPED IN ANTICIPATION OF THE CAROTID PROCEDURE. TREATMENT FOR ALCOHOL WITHDRAWAL WAS GIVEN AND THE PATIENT'S SYMPTOMS COMPLETELY RESOLVED WITHIN 24 TO 36 HOURS AND HE WAS DISCHARGED TO HOME ON (B)(6) 2010. THE SYMPTOMS WERE ASSESSED BY THE TREATING PHYSICIAN TO HAVE BEEN DUE TO ALCOHOL WITHDRAWAL. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-VS 9102451

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR