BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 2962006 · Received February 14, 2013

    Report

    Report Number
    1016427-2013-00018
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE WITHDRAWING THE ANGIOGUARD THROUGH THE PREVIOUSLY IMPLANTED ACCULINK STENT IN THE CAROTID ARTERY THE ANGIOGUARD BASKET CAUGHT ON THE EDGE OF THE STENT. THE TARGET LESION WAS LOCATED AT THE BIFURCATION OF THE LEFT COMMON CAROTID ARTERY AND WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS. AN ANGIOGUARD WAS ADVANCED WITHOUT ANY DIFFICULTY, BUT WAS THEN REMOVED WHEN THE COOK SHEATH INTRODUCER DISLODGED DUE TO DIFFICULT ARCH ANATOMY WHILE ATTEMPTING TO MANEUVER THE PRECISE DELIVERY SYSTEM. THE PHYSICIAN OPENED A SECOND ANGIOGUARD AND WAS UNABLE TO ADVANCE IT TO THE INTENDED LOCATION. THE PHYSICIAN SWITCHED TO AN ABBOTT ACCULINK STENT WHICH WAS PLACED SUCCESSFULLY. AFTER THE OFF-STUDY STENT WAS PLACED THE ANGIOGUARD CAUGHT ON THE DISTAL STENT EDGE DURING WITHDRAWAL. THE DISTAL STENT EDGE WAS BALLOONED ALLOWING THE PHYSICIAN TO SUCCESSFULLY REMOVE THE ANGIOGUARD. THERE WAS NO DEBRIS IN FILTER WHEN CHECKED. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. BASED ON THE INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT OR PRODUCT RETURN IT APPEARS THAT THE DIFFICULTY EXPERIENCED MAY HAVE BEEN CAUSED BY VESSEL CHARACTERISTICS, OPERATIONAL CONTEXT OF THE DEVICE AND/OR DEVICE INTERACTION AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    SUBJECT MOVED RIGHT ARM AND LEG AND SPOKE WITH MD WITHOUT DIFFICULTY JUST BEFORE DROP IN HR AND BP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS DISCHARGED TWO LATER WITH ASPIRIN AND CLOPIDOGREL PRESCRIBED. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING REMOVAL OF THE ANGIOGUARD GUIDEWIRE FROM PATIENT THE OPERATOR ENCOUNTERED RETRIEVAL DIFFICULTY WHEN THE BASKET BECAME CAUGHT ON THE EDGE OF THE IMPLANTED ACCULINK STENT. THE PATIENT IS (B)(6) FEMALE WHO WAS ENROLLED IN THE SAPPHIRE STUDY FOR STENTING OF THE CAROTID ARTERY. THIS SUBJECT HAD A PRE-PROCEDURE STROKE DOCUMENTED WITH A CT SCAN AND ON/OFF SYMPTOMS HAD BEEN OCCURRING FOR APPROXIMATELY TWO WEEKS. THE TARGET LESION WAS LOCATED AT THE BIFURCATION OF THE LEFT COMMON CAROTID ARTERY. THE VESSEL WAS DESCRIBED AS MODERATELY CALCIFIED AND MODERATELY TORTUOUS. AN ANGIOGUARD (601814RMC/ LOT 70812440) EMBOLIC PROTECTION DEVICE WAS ADVANCED. THE ANGIOGUARD WENT IN WITHOUT ANY DIFFICULTY, BUT WAS REMOVED WHEN THE SHEATH DISLODGED DUE TO DIFFICULT ARCH ANATOMY. THE SHEATH DISLODGED FROM THE COMMON CAROTID ARTERY (CCA) WHILE ATTEMPTING TO MANEUVER THE PRECISE STENT THE FIRST TIME. THE PHYSICIAN OPENED A SECOND ANGIOGUARD WITH THE SAME CATALOG AND LOT NUMBER AND WAS UNSUCCESSFUL ON THE SECOND ATTEMPT. THEREFORE, THE PHYSICIAN SWITCHED TO AN ABBOTT ACCULINK STENT FOR FLEXIBILITY AND HE WAS ABLE TO PLACE THAT STENT SUCCESSFULLY. AFTER THE OFF-STUDY STENT WAS PLACED, AND WITHDRAWING THE ANGIOGUARD, THE DEVICE DID CATCH ON THE DISTAL STENT EDGE. THIS REQUIRED A PTA WITH A SMALL BALLOON ON THE DISTAL STENT EDGE BEFORE THE PHYSICIAN COULD SUCCESSFULLY REMOVE THE ANGIOGUARD. AT THE VERY END OF THE CASE, FOLLOWING ACCULINK STENT PLACEMENT AND FILTER RETRIEVAL, THE PHYSICIAN HAD BEEN PREPARING TO USE THE CLOSURE DEVICE IN THE ACCESS ARTERY, WHEN THE SUBJECT HAD A VERY SUDDEN ONSET DROP IN BLOOD PRESSURE AND HER HEART RATE WAS IN 40'S. SHE BECAME APHASIC AND FLACCID ON THE RIGHT SIDE DURING THIS EPISODE, WHICH DID RESPOND TO A FLUID BOLUS, ATROPINE, AND A LOW DOSE DOPAMINE DRIP. THERE WAS NO DEBRIS IN FILTER WHEN CHECKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65651 ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70812440

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR ACCULINK STENT