BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1961877 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00330
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (IMPROPER OR INCORRECT PROCEDURE OR METHOD - DO NOT ATTEMPT TO REPOSITION THE DELIVERY SYSTEM AFTER THE STENT HAS MADE CONTACT WITH THE VESSEL WALL.) THE SELF EXPANDING STENT SYSTEM (SES) WAS RETURNED WITH BLOOD ON THE ENTIRE LENGTH OF THE SES AND NO SALINE VISIBLE. THIS IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE SES WAS ADVANCED INTO THE ANATOMY. THE DISTAL OUTER SHEATH WAS FULLY RETRACTED 5.2 CM PROXIMAL TO THE BASE OF THE TIP, CONSISTENT WITH THE REPORTED INFORMATION THAT THE STENT WAS DEPLOYED AND NOT RETURNED. THERE WAS NO DAMAGE NOTED TO THE SES. DEPLOYMENT DIFFICULTIES CAN BE THE RESULT OF, BUT ARE NOT LIMITED TO, MANUFACTURING, PRE DILATATION STRATEGY, ANATOMICAL CONDITIONS, DEPLOYMENT TECHNIQUE AND/OR DAMAGE TO THE DEVICE DEPLOYMENT MECHANISMS (HANDLE COMPONENTS/SHAFT LUMENS). THERE WAS NO DAMAGE NOTED PRIOR TO USE, SUGGESTING THAT ANATOMICAL CONDITIONS AND/OR INTERACTION WITH ASSOCIATED DEVICES MAY HAVE CONTRIBUTED TO THE DEPLOYMENT DIFFICULTY AND INACCURATE DELIVERY. BECAUSE IT WAS REPORTED THAT THE SES WITH PARTIALLY DEPLOYED STENT WAS DRAGGED BACK INTO THE TARGET LESION, IT SHOULD BE NOTED THAT THE PRODUCT INSTRUCTION FOR USE (IFU) STATES: DO NOT ATTEMPT TO REPOSITION THE DELIVERY SYSTEM AFTER THE STENT HAS MADE CONTACT WITH THE VESSEL WALL. IN THIS CASE, REPOSITION OF THE STENT DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED DEPLOYMENT DIFFICULTY. ADDITIONALLY, IT WAS REPORTED THAT THE CEREBRAL ANGIOGRAM IMAGES TAKEN POST STENT DEPLOYMENT REVEALED POOR CEREBRAL FLOW DUE TO CEREBRAL VESSEL OCCLUSION. THE REPORTED PATIENT EFFECT OF OCCLUSION IS A KNOWN ADVERSE EVENT AS LISTED IN THE PRODUCTS NO FAULT RISK ASSESSMENT REPORT AND INSTRUCTION FOR USE (IFU) AS KNOWN POTENTIAL ADVERSE EFFECTS. 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. IN THIS CASE, REOPRO WAS GIVEN INTRA-ARTERIALLY AND INTRAVENOUSLY TO TREAT THE OCCLUSION. OVERALL, THE REPORTED DEPLOYMENT DIFFICULTIES APPEAR TO BE RELATED TO CASE CIRCUMSTANCES AND THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. EMBOSHIELD NAV 6 EMBOLIC PROTECTION DEVICE (PART 22438-19, LOT 0052551; AND THE EMBOSHIELD NAV 6 RETRIEVAL CATHETER (22438-19, LOT 0102651) ARE BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ATTEMPTED DEPLOYMENT OF AN XACT STENT IN THE LEFT INTERNAL CAROTID ARTERY, THE STENT DELIVERY SYSTEM (SDS) REPEATEDLY JUMPED DISTALLY AND THE STENT PARTIALLY DEPLOYED. THE SDS WITH PARTIALLY DEPLOYED STENT WAS DRAGGED BACK INTO THE TARGET LESION. HOWEVER, AT THE SAME TIME THE WIRE WAS ACCIDENTALLY PULLED AND THE EMBOSHIELD NAV 6 EMBOLIC PROTECTION DEVICE (EPD) WAS PULLED DOWN INTO THE PARTIALLY DEPLOYED STENT. THE STENT WAS THEN FULLY DEPLOYED AND THE EPD WAS REMOVED USING THE RETRIEVAL CATHETER. ANOTHER EPD WAS SUCCESSFULLY DEPLOYED FOR STENT POST- DILATATION. CEREBRAL ANGIOGRAM IMAGES TAKEN POST STENT DEPLOYMENT REVEALED POOR CEREBRAL FLOW DUE TO CEREBRAL VESSEL OCCLUSION. REOPRO WAS GIVEN INTRA-ARTERIALLY AND INTRAVENOUSLY. THE PATIENT WAS ASYMPTOMATIC AND HAD NO NEUROLOGIC DEFICITS. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention EMBOSHIELD NAV 6 EMBOLIC PROTECTION DEVICE