BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1895010 · Received November 5, 2010

    Report

    Report Number
    3004742046-2010-00524
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EMBOSHIELD NAV6 PROTECTION SYSTEM INDICATED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE STENT REMAINS IN THE PT. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PATIENT EFFECT OF RESTENOSIS IS LISTED IN THE PRODUCT INSTRUCTION FOR USE AS A KNOWN POTENTIAL ADVERSE EFFECT ASSOCIATED WITH CAROTID PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE ACTIVATED WITHOUT THE ACTIVATION BUTTON BEING PUSHED. THERE WAS NO PT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2009, A PT UNDERWENT STENTING IN THE LEFT INTERNAL CAROTID ARTERY WITH THE ACCULINK STENT AFTER A FAILED CAROTID ENDARTERECTOMY. ON (B)(6) 2010, THE PT RETURNED WITH IN-STENT RESTENOSIS OF THE ACCULINK STENT. AN EMBOSHIELD NAV6 WAS ADVANCED THROUGH THE ACCULINK STENT AND PRE-DILATATION WAS PERFORMED WITH A 4X20 VIATRAC BALLOON. THE XACT STENT WAS ADVANCED TO TREAT THE IN-STENT RESTENOSIS; HOWEVER, IT COULD NOT BE POSITIONED FOR STENT DEPLOYMENT. THE EMBOSHIELD NAV 6 RECOVERY CATHETER WAS ADVANCED TO RETRIEVE THE FILTER, BUT WAS UNABLE TO CROSS THROUGH THE ACCULINK STENT. REPORTEDLY, THE TECHNICIAN INADVERTENTLY PULLED THE EMBOSHIELD NAV6 WIRE AND THE OPEN FILTER WAS REMOVED THROUGH THE ACCULINK STENT WITH NO ADVERSE PT EFFECTS. THE ACCULINK STENT REMAINED IN PLACE. A 5X20 VIATRAC BALLOON WAS USED TO DILATE THE IN-STENT RESTENOSIS A SECOND TIME. POST PROCEDURE, A CEREBRAL ANGIOGRAM FOUND A CONTRAST LEAK IN THE LEFT MIDDLE CEREBRAL ARTERY M1 SEGMENT, WHICH WAS DISTAL TO THE END OF THE GUIDE WIRE PLACEMENT. DUE THE LOCATION OF THE LEAK, IT WAS NOT POSSIBLE TO TREAT IT. INITIALLY, THE PHYSICIAN DID NOT THINK THE CONTRAST LEAK WAS RELATED TO THE EMBOSHIELD NAV6 GUIDE WIRE, BUT RETROSPECTIVELY FEELS IT IS POSSIBLE THAT THE GUIDE WIRE CAUSED THE PERFORATION. POST PROCEDURE, THE PT WAS FOUND BRADYCARDIC AND HYPOTENSIVE REQUIRING VASOPRESSOR INFUSION. APPROXIMATELY 45 MINUTES POST PROCEDURE, WHILE THE CT SCAN, THE PATIENT'S STATUS DETERIORATED, REQUIRING INTUBATION, AND WAS PRONOUNCED BRAIN DEAD UPON ADMISSION TO THE INTENSIVE CARE UNIT. A CT SCAN SHOWED A LARGE SUBARACHNOID HEMORRHAGE. IT WAS SUSPECTED THAT THE PT HAD A SEIZURE ASSOCIATED WITH THE BLEED AND A BRAIN HERNIATION. PROTAMINE WAS GIVEN TO REVERSE THE EFFECTS OF THE INTRAPROCEDURAL HEPARIN AND THE PT WAS GIVEN DILANTIN FOR THE NEUROLOGICAL STATUS. THE PT WAS ON SUPPORTIVE CARE UNTIL THE PATIENT'S FAMILY CHANGED THE PATIENT'S STATUS TO A DO NOT RESUSCITATE OR NO CODE. THE PT WAS TAKEN OFF LIFE SUPPORT AND EXPIRED ON (B)(6) 2010. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R VESSEL CLOSURE: STARCLOSE| HI-TORQUE SUPRA CORE GUIDE WIRE| 6 FRENCH SHUTTLE SHEATH| DIL CATH: 5 X 20 VIATRAC| 4 X 20 VIATRAC| SHEATH: 4 AND 5 FRENCH STANDARD SHEATH| EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM| OTHER: HEPARIN