BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1600533 · Received February 9, 2010

    Report

    Report Number
    3004742046-2010-00041
    Event Type
    Injury
    Date Received
    February 9, 2010
    Date of Event
    January 14, 2010
    Report Date
    January 15, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (PART# 22437-19/LOT# 9100251) WILL BE FILED UNDER A SEPARATE MFR NUMBER. EVAL SUMMARY: THE DEVICE USED DURING THE PROCEDURE WAS NOT RETURNED WHICH COULD HAVE AIDED IN THE DETERMINATION OF THE CAUSE, HOWEVER, THE DIFFICULTY DURING WITHDRAWAL CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, DAMAGE TO THE DELIVERY SYS, INTERACTION OF THE DELIVERY SYS TO THE OTHER DEVICES, AND INADEQUATE DISTANCE BETWEEN THE STENT AND THE FILTER BASKET DURING DEPLOYMENT OF THE STENT THAT MAY RESULT IN STENT-FILTER BASKET ENTANGLEMENT. THE FILTRATION ELEMENT DURING DEPLOYMENT WAS NOT COMPLETELY APPOSED TO THE VESSEL WALL WHICH RESULTED IN MIGRATION OF THE FILTER FROM THE ORIGINAL LANDING ZONE AND MAY HAVE CONTRIBUTED TO THE DISTAL TIP OF THE DEPLOYED STENT BEING CAUGHT ON THE FILTER BASKET. THE INSTRUCTIONS FOR USE STATES THAT IF A FILTER-BASED EMBOLIC PROTECTION SYSTEM IS USED, ALLOW FOR AND MAINTAIN ADEQUATE DISTANCE BETWEEN THE FILTER AND THE STENT DELIVERY SYSTEM OR DEPLOYED STENT TO AVOID POTENTIAL ENTANGLEMENT. IF FILTER BASKET ENTANGLEMENT OR BASKET DETACHMENT OCCURS, SURGICAL CONVERSION OR COLLAPSING THE BASKET WITH A SECOND STENT SHOULD BE CONSIDERED. A FILTER BASKET MAY NOT COMPLETELY APPOSE TO THE VESSEL WALL IF THE VESSEL DIAMETER IS LARGER THAN THE FILTRATION ELEMENT OR IF THERE IS INADVERTENT MOVEMENT OF THE FILTRATION ELEMENT WHEN IT HAS BEEN DEPLOYED. CLINICAL ANALYSIS INDICATES THAT THE ACCULINK SDS TIP ENGAGED WITH THE EMBOSHIELD BUSHING. THE RX ACCULINK BECAME COMPRESSED AND UPON REMOVAL OF THE EMBOSHIELD, THE RX ACCULINK BECAME MORE COMPRESSED AND DID NOT COVER THE LESION. IT IS UNCLEAR WHETHER THE FILTER SLIPS INTO THE STENT ACCIDENTALLY, OR WHETHER THIS HAPPENS DURING ATTEMPTED REMOVAL OF THE FILTER. BASED ON AVAILABLE INFO, THE CONCLUSIVE CAUSE APPEARS TO BE RELATED TO CIRCUMSTANCES EXPERIENCED DURING THE PROCEDURE. THERE WERE NO INDICATIONS OF ANY PRODUCT DEFICIENCIES WHICH COULD HAVE CONTRIBUTED TO THE OUTCOME OF THE PROCEDURE. AS PART OF MFG QUALITY PROCESS, ALL CATHETERS ARE INSPECTED DURING THE FINAL INSPECTION TO ENSURE PRODUCT STRUCTURE AND INTEGRITY. IN ADDITION, SAMPLES FROM EACH LOT ARE VISUALLY, DIMENSIONALLY AND FUNCTIONALLY INSPECTED. REVIEW OF THE DEVICE LOT HISTORY RECORD SHOWS THAT THIS LOT MET ALL THE IN-PROCESS INSPECTIONS AND TESTS. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES FOR POSSIBLE FUTURE ACTION.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: EMERGENT CEA, UNABLE TO REMOVE FILTER, DAMAGED STENT TIME OF SYMPTOMS/AE: DURING PROCEDURE. IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID STENTING PROCEDURE, THE ACCUNET FILTER CROSSED THE TARGET LESION, BUT WAS NOT DEPLOYED DUE TO INADEQUATE LANDING ZONE. AN EMBOSHEILD NAV6 FILTER WAS THEN USED, SUCCESSFULLY CROSSED THE TARGET LESION AND WAS DEPLOYED, BUT WAS NOT COMPLETELY APPOSED TO THE VESSEL WALL AND MIGRATED DOWN FROM THE ORIGINAL LANDING ZONE. WHEN THE ACCULINK STENT WAS DEPLOYED, THE DISTAL TIP OF THE STENT DELIVERY SYSTEM CAUGHT ON THE NAV6 FILTER. THE STENT DELIVERY SYS WAS WITHDRAWN AFTER "SOME DIFFICULTY." THERE WAS DIFFICULTY IN ADVANCING THE NAV6 RETRIEVAL CATHETER ACROSS THE DISTAL TIP OF THE DEPLOYED STENT. THE FILTER WAS COLLAPSED AND RETRIEVED WITH DIFFICULTY THROUGH THE DISTAL PART OF THE STENT. IT IS SUSPECTED THAT THE NAV6 FILTER CAUSED DAMAGE TO THE DISTAL PART OF THE STENT DURING FILTER RETRIEVAL. TO TREAT THE SUSPECTED STENT DAMAGE, A NON-ABBOTT SPYDER FX FILTER WAS ADVANCED THROUGH THE STENT AND THE FILTER WAS DEPLOYED WITHOUT INCIDENT. A VIATRAC BALLOON DILATATION CATHETER SUCCESSFULLY POST-DILATED THE STENT AND THE DILATATION CATHETER WAS REMOVED WITHOUT INCIDENT. UPON REMOVAL OF THE NON-ABBOTT FILTER, THE FILTER BECAME ENTANGLED WITHIN THE STENT, REQUIRING AN ENDARTERECTOMY TO REMOVE BOTH THE STENT AND FILTER. THE PT REMAINED HEMODYNAMICALLY AND NEUROLOGICALLY STABLE. THE PT WAS DISCHARGED HOME THREE DAYS POST OPERATIVELY. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9050851

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R EMBOLIC PROTECTION: EV3 SPIDERFX| RX ACCUNET| DIL CATH: VIATRAC 4X20X135| OTHER: HEPARIN