BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1966964 · Received January 21, 2011

    Report

    Report Number
    2024168-2011-00417
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: 4.0X20MM, 5.0X20MM VIATRAC PLUS; 5.0X 30MM VIATRAC; 4.0X40MM FOX SV(83162-02); 5.0X 60 MM(12766-06), 8.0X20MM 9.0X20MM FOX PLUS; 3.0, 3.5, 4.0 X 20MM VOYAGER RX GUIDE WIRE: TERUMO .035 ANGLED GLIDE WIRE 260CM; SUPRA CORE .035 X300 CM;(1002703-02); ASAHI GRAND SLAM; GUIDE CATHETER: CORDIS BRITE TIP 8 FR; 8 FR ABBOTT GUIDE LIMASHEATH: 5 FR, 8 FR MERIT MEDICAL PRELUDE PRO SHEATH; COOK 6 FR SHUTTLE SHEATHSTENT: 6.0 X 100MM ABSOLUTE PRO((B)(4)); 10X30MM XACT; 8.0 X28MM, 7.0 X18MM 7.0 X28MM OMNILINK; 8.0 X38 OMNILINK, 7.0 X18MM HERCULINK ELITEOTHER: HEPARIN THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE 8.0 X 38 MM (1007948-38, LOT# 0050751) OMNILINK, IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY ISSUE. IT APPEARS THAT THE LESION SITE CONTRIBUTED TO THE DIFFICULTY CROSSING, AS IT WAS REPORTED THAT THE EMBOLIC PROTECTION SYSTEM (EPS) WAS ABLE TO CROSS AFTER MULTIPLE PRE-DILATATIONS. ADDITIONALLY, DIFFICULTY RETRIEVING THE FILTRATION ELEMENT MAY INCLUDE, BUT IS NOT LIMITED TO, PATIENT ANATOMICAL CONDITIONS, STENT POST DILATATION STRATEGY, THE NEWLY DEPLOYED STENT NOT BEING FULLY APPOSED TO THE VESSEL WALL, LACK OF GUIDE CATHETER SUPPORT OR INTERACTION BETWEEN ASSOCIATED DEVICES. BASED ON THE REPORTED INFORMATION, IT APPEARS THAT THE DIFFICULTY RETRIEVING THE EPS WAS DUE TO THE PARTIALLY DISLODGED OMNILINK STENT WHICH COULD NOT BE PULLED BACK INTO THE SHEATH, PREVENTING THE EPS RETRIEVAL. EVENTUALLY, THE OMNILINK STENT WAS DEPLOYED IN THE DISTAL ABDOMINAL AORTA ALLOWING RETRIEVAL OF THE EPD THROUGH THE SHEATH USING THE EPS RETRIEVAL CATHETER. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. ADDITIONALLY, THE LOT RELEASE TESTING RESULTS WERE REVIEWED AND ALL SAMPLES MET ALL MANUFACTURING CRITERIA. OVERALL, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CASE CIRCUMSTANCES AND THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. AS PART OF THE MANUFACTURING QUALITY PROCESS, ALL EMBOLIC PROTECTION DEVICES ARE VISUALLY INSPECTED FOR DAMAGE. IN ADDITION, A SAMPLING OF UNITS IS VISUALLY, DIMENSIONALLY AND FUNCTIONALLY INSPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LENGTHY 5 HOUR PROCEDURE OF THE RIGHT SUBCLAVIAN AND RIGHT COMMON CAROTID (RCC) ARTERY, AFTER MULTIPLE PRE-DILATATIONS THE EMBOSHIELD NAV6 EMBOLIC PROTECTION DEVICE (EPD) WAS DEPLOYED IN THE RCA AFTER 2 UNSUCCESSFUL ATTMPTS TO CROSS THE LESION. THE 10X30MM XACT STENT DELIVERY SYSTEM (SDS) AND 8 MM X 38 MM OMNILINK SDS COULD NOT CROSS THE SEVERE TORTUOUS PROXIMAL LESION; DURING RETRIEVAL OF THE OMNILINK, THE STENT PARTIALLY DISLODGED FROM THE BALLOON. THE ENTIRE SYSTEM WAS REMOVED INCLUDING THE EPD FROM THE CAROTID ARTERY INTO THE DISTAL ABDOMINAL AORTA. THE PARTIALLY DISLODGED STENT COULD NOT PASS INTO THE 8 FR SHEATH IN THE ABDOMINAL AORTA AND THE EPD COULD NOT BE RETRIEVED. THE STENT WAS DEPLOYED IN THE DISTAL ABDOMINAL AORTA ALLOWING RETRIEVAL OF THE EPD THROUGH THE SHEATH USING THE EPD RETRIEVAL CATHETER. THERE APPEARED TO BE A MODERATE RESIDUAL STENOSIS/DISSECTION AT THE PROXIMAL EDGE OF THE DISTAL ABDOMINAL AORTIC STENT. THIS WAS TREATED WITH A 9 MM X 28 MM OMNILINK; BOTH STENTS WERE POSTDILATED WITH A 9 MM AND 10 MM BALLOON; RESULTING IN GOOD STENT APPOSITION. AT THE CONCLUSION OF THE CASE, RIGHT RADIAL AND BRACHIAL PULSES WERE INTACT. DURING THE PROCEDURE THE PATIENT WAS NOTED TO HAVE TRANSIENT BRADYCARDIA WHICH RESOLVED AND MILD HYPOTENSION WHICH WAS TREATED WITH NEOSYNEPHRINE; THE PATIENT REMAINED NEUROLOGICALLY STABLE. REPORTEDLY, THE PATIENT HAD AN EXTENDED HOSPITALIZATION; THE DATE OF DISCHARGE WAS NOT REPORTED. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 0091251

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention