BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 3210287 · Received July 8, 2013

    Report

    Report Number
    2024168-2013-04255
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 14, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE PHYSICAL RESISTANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL AND DIMENSIONAL 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. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EMBOSHIELD NAV6 EMBOLIC PROTECTION FILTER WAS ADVANCED VIA FEMORAL ACCESS PAST A MILDLY CALCIFIED, 95% RESTENOSED LESION IN THE MID AREA OF A MILDLY TORTUOUS SAPHENOUS VEIN GRAFT TO THE RIGHT CORONARY ARTERY, FOLLOWED BY DEPLOYMENT OF TWO NON-ABBOTT DRUG-ELUTING STENTS THEN POST-DILATATION OF THE STENTS USING AN UNSPECIFIED 3-MILLIMETER BALLOON. WHEN ATTEMPTING TO RETRIEVE THE NAV6 FILTER USING THE NAV6 RETRIEVAL CATHETER, THE RETRIEVAL CATHETER WAS UNABLE TO CROSS THROUGH THE PLACED STENTS. THE NAV6 RETRIEVAL CATHETER WAS WITHDRAWN AND STENTS WERE POST-DILATED AGAIN. THE SAME NAV6 RETRIEVAL CATHETER WAS RE-ADVANCED, BUT STILL UNABLE TO CROSS THROUGH THE STENTS. THE PHYSICIAN PULLED THE FILTER (WHILE STILL IN THE OPEN POSITION) THROUGH THE STENTS TO THE MID AREA OF THE STENTS WHERE THE FILTER WAS ABLE TO BE CAPTURED WITH THE HELP OF THE NAV6 RETRIEVAL CATHETER; NO EMBOLIC MATERIAL RELEASED INTO THE BLOODSTREAM WHEN REMOVING THE FILTER. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310155 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 2070962

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STENT: PRONOVA