BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX

    MDR report key: 1208198 · Received October 21, 2008

    Report

    Report Number
    1016427-2008-00275
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 23, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS STUDY PT UNDERWENT CAROTID STENT IMPLANTATION AND DURING THE ANGIOGUARD REMOVAL, THERE WAS DIFFICULTY REMOVING THE DEVICE AND THE FILTER BASKET WAS DAMAGED IN THE PT. THE PT IS A MALE WITH MEDICAL HISTORY INCLUDING CANCER AND RADIATION TREATMENT. THE PT MEETS THE HIGH-RISK CRITERIA OF AGE GREATER THAN 75 YEARS AND STATUS POST RADIATION THERAPY AND TRACHEOTOMY STOMA IN PLACE. THE TARGET LESION WAS RIGHT INTERNAL CAROTID ARTERY DESCRIBED AS ECCENTRIC, SEVERELY CALCIFIED, SEVERELY TORTUOUS AND 80% STENOTIC. THE ANGIOGUARD WAS PREPPED AND HANDLED PER THE IFU. THE ANGIOGUARD WAS INSERTED, TRACKED AND DEPLOYED AT THE TARGET LESION WITHOUT REPORTED DIFFICULTIES. ONE PRECISE STENT WAS IMPLANTED WITHOUT REPORTED DIFFICULTIES. AFTER STENT IMPLANTATION, THE ANGIOGUARD WAS BEING REMOVED AND IT BECAME "HUNG UP" ON THE STENT. DURING THE MANIPULATIONS TO REMOVE THE ANGIOGUARD, PART OF THE FILTER MEMBRANE WAS PULLED OFF OF THE STRUTS. THE DEVICE WAS REMOVED INTACT FROM THE PT; NO PORTION WAS RETAINED WITHIN THE PT. THERE WAS NO REPORTED INJURY FOR THE PT. NO FURTHER INFORMATION WAS AVAILABLE REGARDING THIS COMPLAINT DESPITE MULTIPLE REQUESTS. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. THE PRODUCT WAS NOT RETURNED TO LAKE REGION MEDICAL FOR EVALUATION; HOWEVER, A COPY OF THE INVESTIGATION REQUEST INCLUDING LOT TRACEABILITY WAS PROVIDED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, LAKE REGION MEDICAL IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THIS LOT. THIS PACKAGING LOT CONTAINED 172 UNITS, WHICH WERE SHIPPED FOR LAKE REGION MEDICAL ON AUGUST 9, 2007. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE COMPLAINTS OF WITHDRAWAL DIFFICULTY AND FILTER BASKET DAMAGED IN PT COULD NOT BE CONFIRMED SECONDARY TO THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY. REVIEW OF THE INFORMATION SUGGESTS THAT THERE WERE PROCEDURAL AND VESSEL FACTORS THAT MAY HAVE CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER. THE IFU CAUTIONS, "NEVER PULL THE ANGIOGUARD EMBOLI CAPTURE GUIDEWIRE INTO THE GUIDING CATHETER OR INTERVENTIONAL SHEATH INTRODUCER IF THERE IS RESISTANCE. IF RESISTANCE IS ENCOUNTERED, REPOSITION THE CAPTURE SHEATH TO ENSURE THAT THE FILTER BASKET IS PROPERLY SEATED INTO THE CAPTURE SHEATH. USING FLUOROSCOPY, VERIFY CAPTURE SHEATH POSITION BY CHECKING MARKER BAND ALIGNMENT BETWEEN THE CAPTURE SHEATH AND THE GUIDEWIRE. REPOSITION THE CAPTURE SHEATH IF NECESSARY."

    Description of Event or Problem · 1

    THE PT WAS ENROLLED IN THE STUDY IN 2008 WITH AN 80% LESION AT THE OSTIUM OF THE INTERNAL CAROTID ARTERY. THE LESION WAS ECCENTRIC AND SEVERELY CALCIFIED AND WAS 20MM IN LENGTH. THE VESSEL WAS SEVERELY TORTUOUS AND WAS 5.5 MM IN DIAMETER. AN ANGIOGUARD WAS SUCCESSFULLY DEPLOYED AND A PRECISE STENT WAS IMPLANTED. POST PROCEDURE STENOSIS WAS 20%. WHILE REMOVING THE ANGIOGUARD THROUGH THE STENT, IT BECAME "HUNG UP". PART OF THE POLYURETHANE WAS PULLED OFF OF THE FILTER. THERE WAS NO ADVERSE EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70707510

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR