BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1914705 · Received December 3, 2010

    Report

    Report Number
    3004742046-2010-00579
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EMBOLIC PROTECTION SYSTEM (EPS) WAS RETURNED WITH BLOOD ON THE DELIVERY CATHETER (DC), RETRIEVAL CATHETER (RC), FILTRATION ELEMENT AND BARE WIRE AND NO SALINE VISIBLE. THIS IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE HAD BEEN ADVANCED INTO THE ANATOMY. ONLY THE DC, RC, FILTRATION ELEMENT AND BARE WIRE WERE RETURNED. THE FILTRATION ELEMENT WAS RETURNED FULLY LOADED INTO THE DC POD. ALTHOUGH NOT REPORTED, THE DC POD WAS SEPARATED AT THE PROXIMAL END OF THE MARKER BAND. THE MATERIAL AT THE SEPARATION WAS JAGGED. THERE WERE OFFSET AND OVERLAPPING INTERMEDIATE COILS ON THE BARE WIRE PROXIMAL TO THE STEP, FOR A LENGTH OF 3 MM. THERE WERE TWO KINKS IN THE CORE 2.4 CM AND 3 CM PROXIMAL TO THE STEP. THERE WAS A BEND IN THE TIP 3 MM PROXIMAL TO THE TIP BALL. THERE WERE TWO BENDS IN THE CORE 71 CM AND 76 CM DISTAL TO THE PROXIMAL END OF THE BARE WIRE. THERE WAS NO OTHER DAMAGE NOTED TO THE EPS. THE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE WAS INTACT. THE DIFFICULTY ADVANCING THE SYSTEM MAY BE RELATED TO ANATOMICAL CONDITIONS, AS IT WAS REPORTED THAT THE ANATOMY WAS TORTUOUS. ADDITIONALLY, THE DIFFICULTY ADVANCING LIKELY CAUSED THE OFFSET/OVERLAPPING INTERMEDIATE COILS AND KINKS NOTED ON THE BARE WIRE, AS THIS TYPE OF DAMAGE TO THE WIRE IS CONSISTENT WITH PUSHING/PULLING AGAINST RESISTANCE. FAILURE TO DEPLOY CAN BE A RESULT OF, BUT IS NOT LIMITED TO, MANUFACTURING, PRE DILATATION STRATEGY, ANATOMICAL CONDITIONS, DEPLOYMENT TECHNIQUE AND/OR DAMAGE TO THE DELIVERY CATHETER. IN THIS CASE, IT APPEARS THAT THE SEPARATION OF THE DELIVERY CATHETER POD LIKELY CONTRIBUTED TO THE FAILURE TO DEPLOY. ALTHOUGH THE SEPARATION WAS NOT REPORTED AND A CONCLUSIVE CAUSE COULD NOT BE DETERMINED, IT MAY BE POSSIBLE THAT THE SEPARATION OCCURRED AS A RESULT OF PUSHING/PULLING WITH FORCE AGAINST RESISTANCE WHILE ADVANCING. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT AND THERE HAVE BEEN NO OTHER INCIDENTS FOR FAILURE TO DEPLOY OR DIFFICULT TO POSITION REPORTED FOR THIS LOT. A CONCLUSIVE CAUSE FOR THE REPORTED FAILURE TO DEPLOY AND NOTED DAMAGE TO THE DELIVERY CATHETER AND BARE WIRE COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL INTERNAL CAROTID ARTERY AND COMMON CAROTID WAS TORTUOUS AND THERE WAS DIFFICULTY TRACKING THE DEVICE TO THE PARKING LOT. AN ATTEMPT WAS MADE TO DEPLOY THE DEVICE; HOWEVER, IT WOULD NOT DEPLOY AND IT WAS REMOVED WITH NO ISSUE. A FILTER WIRE WAS THEN USED WITH SUCCESS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. THE RETURNED DEVICE REVEALED A SEPARATION AT THE PROXIMAL END OF THE MARKER BAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA 0072652

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR