BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 1887599 · Received October 22, 2010

    Report

    Report Number
    3004742046-2010-00500
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    NTE
    PMA / PMN Number
    K052166
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE EMBOSHIELD NAV6 ((B)(4), LOT 0082351) INDICATED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. EVALUATION SUMMARY: THERE ARE SEVERAL POSSIBLE CAUSES FOR DIFFICULTY ADVANCING THE RETRIEVAL CATHETER, INCLUDING, BUT NOT LIMITED TO, DAMAGE TO THE DELIVERY CATHETER, CHALLENGING 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. IN THIS CASE, BASED ON THE REPORTED INFORMATION, IT APPEARS THAT THE DIFFICULTY OF ADVANCING THE RETRIEVAL CATHETER IS DUE TO INTERACTION WITH THE NEWLY PLACED STENT. IT MAY BE POSSIBLE THAT THE STENT WAS NOT FULLY APPOSED TO THE VESSEL WALL OR IMPLANTED IN AN ANGLED SEGMENT OF THE ARTERY RESULTING IN INTERACTION BETWEEN THE RETRIEVAL CATHETER AND THE STENT DURING ADVANCEMENT. REPORTEDLY, ATTEMPTS TO CROSS USING THE NAV6 RECOVERY CATHETER WERE ALSO UNSUCCESSFUL, FURTHER SUGGESTING THAT THE DIFFICULTY IS LIKELY RELATED TO THE ANATOMICAL CONDITIONS OR STENT APPOSITION. WITHOUT THE PRODUCT, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY OF RETRIEVING THE FILTRATION ELEMENT COULD NOT BE DETERMINED. HOWEVER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL EMBOLIC PROTECTION DEVICES AND RETRIEVAL CATHETERS 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 A PHYSICIAN, TRAINED IN THE USE OF THE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED AND A SECOND PROGLIDE WAS USED SUCCESSFULLY TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE HEAVILY CALCIFIED RIGHT INTERNAL/COMMON ARTERY, THE NAV6 RECOVERY CATHETER WAS ADVANCED, BUT COULD NOT RETRIEVE THE FILTER BECAUSE IT BECAME CAUGHT ON THE STENT. THE RECOVERY CATHETER WAS REMOVED FROM THE ANATOMY AND AN RX ACCUNET RECOVERY CATHETER 1 AND 2 WERE ADVANCED SEPARATELY, BUT COULD NOT RETRIEVE THE FILTER. AFTER THE RX ACCUNET RECOVERY CATHETER #2 WAS REMOVED FROM THE ANATOMY, THE BAREWIRE WAS INADVERTENTLY PULLED AND THE FILTER PULLED THROUGH THE STENT AND WAS RETRIEVED FROM THE ANATOMY. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR - VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention EMBOSHIELD NAV6 ((B)(4), LOT 0082351)| STENT: XACT (B)(4)| GUIDE WIRE: SUPRACORE