BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD EMBOLIC PROTECTION SYSTEM

    MDR report key: 1980808 · Received February 7, 2011

    Report

    Report Number
    2024168-2011-00741
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K052454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. DILATATION CATHETER: 4.0X8 MM UNKNOWN BALLOON; GUIDE WIRE: IQ; GUIDE CATH: 6FR LCB; STENT: 5.0 X 13 MM ULTRA (B)(4). (B)(4) - INDICATION FOR USE. THE 5.0 X 13 MM ULTRA (B)(4) IS BEING FILED UNDER A SEPARATE MFR NUMBER. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT THROMBOSIS IS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU) AS A KNOWN POTENTIAL ADVERSE EFFECT ASSOCIATED WITH CAROTID PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. AS IT WAS REPORTED THAT THE EMBOSHIELD NAV 6 WAS BEING USED TO TREAT A SAPHENOUS VEIN GRAFT, IT SHOULD BE NOTED THAT THE IFU STATES: THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM IS INDICATED FOR USE AS A GUIDE WIRE AND EMBOLIC PROTECTION SYSTEM TO CONTAIN AND REMOVE EMBOLIC MATERIAL (THROMBUS/DEBRIS) WHILE PERFORMING ANGIOPLASTY AND STENTING PROCEDURES IN CAROTID ARTERIES. THE DIAMETER OF THE ARTERY AT THE SITE OF THE FILTRATION ELEMENT PLACEMENT SHOULD BE BETWEEN 2.5 AND 7.0 MM. IN THIS CASE, THE OFF-LABEL USE DOES NOT APPEAR TO HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EFFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT TO THE OBTUSE MARGINAL. PRIOR TO PREDILATATION WITH AN NON-ABBOTT BALLOON CATHETER AN EMBOSHIELD FILTER WAS ADVANCED FOR PROTECTION DISTALLY, AND AFTER PREDILATATION WAS PERFORMED THE FILTER WAS REMOVED. ADDITIONALLY, AFTER PREDILATATION WAS PERFORMED, THE VESSEL WAS NOTED TO HAVE STARTED TO FORM THROMBUS; HOWEVER, NO TREATMENT FOR THE THROMBUS WAS PERFORMED AT THIS TIME. THE VESSEL HAD A STENT ALREADY IMPLANTED IN THE PROXIMAL PORTION OF THE GRAFT, FROM A PREVIOUS PROCEDURE. AN ATTEMPT WAS MADE TO USE AN ACCULINK STENT AS THE VESSEL WAS LARGE IN DIAMETER; HOWEVER, THE DELIVERY SYSTEM WOULD NOT ADVANCE THROUGH THE GUIDING CATHETER. AN ATTEMPT WAS THEN MADE TO USE A HERCULINK STENT; HOWEVER, THIS WOULD NOT CROSS THROUGH THE PROXIMAL STENT TO THE LESION AND WAS REMOVED FROM THE PATIENT. A 4.5 X 18 MM ULTRA STENT WAS DEPLOYED IN THE MID GRAFT SUCCESSFULLY. THE 5.0 X 13 ULTRA STENT WAS ADVANCED IN AN ATTEMPT TO TREAT DISTALLY; HOWEVER, THIS RESULTED IN THE STENT DISLODGING FROM THE BALLOON WHEN IT CAUGHT ON THE DEPLOYED STENT AND MIGRATED DOWN INTO THE DISTAL VESSEL. A 5.0 X 28 MM ULTRA STENT WAS USED TO CRUSH THE DISLODGED STENT AGAINST THE VESSEL WALL. POST DILATATION WAS PERFORMED; HOWEVER, THROMBUS WAS SEEN FORMING THROUGHOUT THE GRAFT, A 4.5 X 13 ULTRA WAS DEPLOYED TO TREAT THE THROMBUS AND A THROMBECTOMY WAS ALSO PERFORMED. STILL THROMBUS WAS NOTED PROXIMAL TO THE DEPLOYED 4.5 X 13 ULTRA. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention