BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ANGIOGUARD

    MDR report key: 7145835 · Received December 26, 2017

    Report

    Report Number
    1016427-2017-00909
    Event Type
    Injury
    Date Received
    December 26, 2017
    Date of Event
    June 25, 2003
    Report Date
    January 8, 2018
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NOTED IN A 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; INDICATE THAT FILTER CLOTTING WAS RECORDED IN FOUR OF FIVE PATIENTS IN GROUP A (CONCENTRIC STENOSIS) AND TWO OF FOUR PATIENTS IN GROUP BAND C (CHRONIC OCCLUSION AND CALCIFIED STENOSIS). THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE FUNCTION OF AN EMBOLIC PROTECTION DEVICE IS TO CAPTURE DEBRIS DURING THE CAROTID PROCEDURE AND PREVENT IT FROM EMBOLIZING DOWNSTREAM INTO THE PATIENT¿S VASCULATURE. WITHOUT MEDICAL RECORDS OR PROCEDURAL FILMS AVAILABLE FOR REVIEW, THE REPORTED FILTER CLOTTING COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION CHARACTERISTICS. PER THE INSTRUCTIONS FOR USE (IFU) ¿IF DISTAL PERFUSION OF DYE IS SIGNIFICANTLY REDUCED OR NO DYE IS PERFUSING PAST THE DISTAL MARKER BAND OF THE FILTER BASKET, THE ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE MAY HAVE REACHED ITS MAXIMUM CAPACITY TO CONTAIN EMBOLI. REMOVE AND REPLACE WITH A NEW ANGIOGUARD RX SYSTEM.¿ GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE DESIGN, MANUFACTURING PROCESS OR IMPLANTATION OF THE DEVICE; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    KÖNIG, C. W., PUSICH, B., TEPE, G., WENDEL, H., HAHN, U., SCHNEIDER, W., . . . DUDA, S. H. (2003). FREQUENT EMBOLIZATION IN PERIPHERAL ANGIOPLASTY: DETECTION WITH AN EMBOLISM PROTECTION DEVICE (ANGIOGUARD) AND ELECTRON MICROSCOPY. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 26(4), 334-339. DOI:10.1007/S00270-003-2656-3. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS NOTED IN A 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; INDICATE THAT FILTER CLOTTING WAS RECORDED IN FOUR OF FIVE PATIENTS IN GROUP A (CONCENTRIC STENOSIS) AND TWO OF FOUR PATIENTS IN GROUP BAND C (CHRONIC OCCLUSION AND CALCIFIED STENOSIS; FIG.1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925554 UNKNOWN ANGIOGUARD TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE CORDIS CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| S