BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 3111888 · Received May 14, 2013

    Report

    Report Number
    2024168-2013-03031
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. THE PATIENT'S AGE AND WEIGHT ARE ESTIMATED. CONCOMITANT PRODUCTS: GUIDE WIRE: 017 VIPER, 014, 018, SHEATH: 6 FRENCH, COOK CXI CATHETER. (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED PEELING WAS UNABLE TO BE CONFIRMED, HOWEVER, THE SEPARATION WAS CONFIRMED. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. BASED ON A VISUAL, DIMENSIONAL, FUNCTIONAL, SCANNING ELECTRON MICROSCOPY IMAGING, AND CHEMICAL ANALYSIS INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. THE REPORTED PATIENT EFFECTS OF DISSECTION, EMBOLISM, OCCLUSION, AND PAIN ARE LISTED IN THE DEVICE INSTRUCTIONS FOR USE (IFU) AS POTENTIAL PATIENT EFFECTS OF THE PROCEDURE. IT SHOULD BE NOTED THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM ELECTRONIC IFU STATES: THE EMBOSHIELD NAV6 DEVICE CAN ONLY BE USED WITH THE BAREWIRE FILTER DELIVERY WIRE. USE OF THE DEVICE WITH ANY GUIDE WIRE OTHER THAN THE BAREWIRE FILTER DELIVERY WIRE WILL LEAD TO LOSS OF THE FILTRATION ELEMENT DURING THE PROCEDURE OR AN INABILITY TO RETRIEVE THE FILTRATION ELEMENT. THE IFU FURTHER STATES: THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM IS INDICATED FOR USE AS AN EMBOLIC PROTECTION SYSTEM TO CONTAIN AND REMOVE EMBOLIC MATERIAL WHILE PERFORMING ANGIOPLASTY AND STENTING PROCEDURES IN CAROTID ARTERIES. BASED ON THE INFORMATION REVIEWED, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PROXIMAL SHAFT OF THE EMBOSHIELD NAV6 RETRIEVAL CATHETER SEPARATED DURING REMOVAL FROM THE ANATOMY. THE SEPARATED SEGMENT WAS REMOVED WHEN ALL THE DEVICES WERE REMOVED AS ONE UNIT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EMBOSHIELD NAV6 FILTER THAT HAD BEEN LOADED OVER A NON-ABBOTT 017 GUIDEWIRE, WAS DEPLOYED AT THE POPLITEAL ARTERY, BELOW THE MODERATELY CALCIFIED TARGET LESION IN THE LEFT, MID SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS TREATED WITH A CSI ATHERECTOMY DEVICE AND IT WAS NOTED THAT THERE WAS SOME SLOW BLOOD FLOW PAST THE FILTER. THE DECISION WAS MADE TO RETRIEVE THE FILTER. THE FILTER WAS COMPLETELY CAPTURED WITH THE RETRIEVAL CATHETER (RC) AND WITHDRAWAL OF THE RC WAS ATTEMPTED, WHILE SIMULTANEOUSLY ADVANCING THE GUIDEWIRE DISTAL TO PREVENT LOSS OF VESSEL ACCESS. A BUDDY WIRE WAS ADVANCED TO THE LEVEL OF THE BIFURCATION WHEN IT WAS NOTED THAT THERE WAS A LOOP ADJACENT TO THE RC. THE BUDDY WIRE WAS REMOVED FIRST AND IT WAS THEN DECIDED THAT THE GUIDEWIRE AND THE RC WITH THE FILTER, SHOULD BE REMOVED TOGETHER AS A SINGLE UNIT. IT IS SURMISED THAT THE LOOP THAT WAS SEEN ON FLUOROSCOPY WAS ACTUALLY PART OF THE RC THAT HAD PEELED TO SOME DEGREE AT THE RC EXIT NOTCH. THERE MAY HAVE BEEN EXCESSIVE FORCE APPLIED TO THE GUIDEWIRE DURING ADVANCEMENT OF THE WIRE AND THE SIMULTANEOUS REMOVAL OF THE RC, NOT DUE TO RESISTANCE IN THE ANATOMY, BUT TO PREVENT LOSS OF THE VESSEL ACCESS. DURING THE PROCEDURE, IT WAS ALSO NOTED THAT THERE WAS NO FLOW AT THE ANTERIOR TIBIAL (AT) ARTERY AND THERE WAS A DISSECTION IN THE PROXIMAL SFA, THAT MAY HAVE OCCURRED DURING REMOVAL OF THE RC. THE LOSS OF FLOW IN THE AT IS SURMISED TO BE DUE TO THREE POSSIBLE CAUSES: 1. THE GUIDEWIRE MAY HAVE CAUSED THE DISSECTION, 2. THE FILTER MAY NOT HAVE CAPTURED ALL OF THE THROMBUS/DEBRIS, 3. THE RC MAY HAVE DISLODGED PLAQUE DURING REMOVAL ATTEMPTS OF THE RC. THE VESSEL WAS RE-ACCESSED AND STENTING WITH NON-ABBOTT STENTS WAS PERFORMED TO TREAT THE DISSECTION IN THE PROXIMAL SFA. GOOD RUNOFF WAS ACHIEVED WITH THE STENTING AND THE DISSECTION WAS SEALED. DURING THE PROCEDURE, THE PATIENT COMPLAINED OF FOOT PAIN. AT SOME POINT DURING THE PROCEDURE, THE PATIENTS ACTIVATED CLOTTING TIME (ACT) WAS AT 145 SECONDS WHICH IS BELOW THE THERAPEUTIC RANGE. 7000 UNITS OF HEPARIN WAS ADMINISTERED TO BRING THE ACT BACK TO THERAPEUTIC RANGE. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS IN STABLE CONDITION. AFTER THE FILTER WAS REMOVED FROM THE PATIENT, THE FILTER BASKET WAS NOTED TO BE PARTIALLY FULL. THE PATIENT UNDERWENT FASCIOTOMY SURGERY TO FIX THE OUTFLOW TO THE FOOT AND INFLOW TO THE HEART. POST OPERATIVELY, THE PATIENT WAS IN GOOD CONDITION WITH GOOD VIABILITY TO THE MUSCLE AND FOOT. IT WAS THEN FOUND, THAT EMBOLI WAS THE CAUSE OF THE AT LOSS OF FLOW. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212043 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 2041261

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention