BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ANGIOGUARD

    MDR report key: 7151993 · Received December 28, 2017

    Report

    Report Number
    1016427-2017-00924
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    June 25, 2003
    Report Date
    December 28, 2017
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: KONIG, C. W. (2003). FREQUENT EMBOLIZATION IN PERIPHERAL ANGIOPLASTY: DETECTION WITH AN EMBOLISM PROTECTION DEVICE (ANGIOGUARD) AND ELECTRON MICROSCOPY. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 26(4), 334-339. COMPLAINT CONCLUSION: AS NOTED IN THE LITERATURE PUBLICATION, KONIG ET AL FREQUENT EMBOLIZATION IN PERIPHERAL ANGIOPLASTY: DETECTION WITH AN EMBOLISM PROTECTION DEVICE (ANGIOGUARD) AND ELECTRON MICROSCOPY, CARDIOVASC INTERVENT RADIOL (2003) 26:334¿339; EMBOLIZATION ASSOCIATED WITH FILTER DEPLOYMENT WAS DEMONSTRATED IN A MINIMUM OF TWO OF FIVE PATIENTS. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. AN ANGIOGUARD FILTER IS INDICATED FOR USE AS A GUIDEWIRE AND EMBOLIC PROTECTION SYSTEM TO CONTAIN AND REMOVE EMBOLIC MATERIAL (THROMBUS/DEBRIS) WHILE PERFORMING CAROTID ARTERY ANGIOPLASTY AND STENTING PROCEDURES IN CAROTID ARTERIES FOR PATIENTS IN WHICH ANTIPLATELET AND/OR ANTICOAGULANT THERAPY IS CONTRAINDICATED, THE GUIDE CATHETER IS UNABLE TO BE PLACED, HAVE UNCORRECTED BLEEDING DISORDERS, KNOWN ALLERGIES TO NITINOL, AND LESIONS IN THE OSTIUM OF THE COMMON CAROTID ARTERY. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE AS AN EMBOLI PROTECTION SYSTEM HAS NOT BEEN ESTABLISHED IN THE CORONARY, CEREBRAL, OR PERIPHERAL VASCULATURE, OTHER THAN CAROTID ARTERIES. EMBOLISM DOES NOT REPRESENT A DEVICE MALFUNCTION. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION CHARACTERISTICS. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE DESIGN AND/OR MANUFACTURING PROCESS OF THE DEVICE; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    AS NOTED IN THE LITERATURE PUBLICATION, KONIG ET AL FREQUENT EMBOLIZATION IN PERIPHERAL ANGIOPLASTY: DETECTION WITH AN EMBOLISM PROTECTION DEVICE (ANGIOGUARD) AND ELECTRON MICROSCOPY, CARDIOVASC INTERVENT RADIOL (2003) 26:334¿339; EMBOLIZATION ASSOCIATED WITH FILTER DEPLOYMENT WAS DEMONSTRATED IN A MINIMUM OF TWO OF FIVE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932477 UNKNOWN ANGIOGUARD TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE CORDIS CORPORATION AGXXXX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening