BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX

    MDR report key: 1048225 · Received May 19, 2008

    Report

    Report Number
    1016427-2008-00148
    Event Type
    Injury
    Date Received
    May 19, 2008
    Date of Event
    April 18, 2008
    Report Date
    April 21, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON WAS REMOVED. AFTER THE BALLOON WAS REMOVED, THE PT COMPLAINED THAT SHE COULD NOT SEE OUT OF HER RIGHT EYE. THE PHYSICIAN REMOVED THE ANTIOGUARD DEVICE. A FINAL RIGHT CEREBRAL ANGIOGRAM WAS PERFORMED. ALL CATHETERS AND GLIDEWIRES WERE REMOVED FROM THE PT. AT THIS POINT, THE PT HAD NORMAL SPEECH AND FACIAL EXPRESSION. THERE WAS ALSO NORMAL LIMB MOVEMENT. THE PT CLAIMED THAT HER SIGHT IS GETTING BETTER IN THE RIGHT EYE. THE PROCEDURE WAS COMPLETED. INTEGRILIN WAS GIVEN (10ML/HR). THE PT WAS NEUROLOGICALLY INTACT WHEN TAKEN FROM THE ANGIO SUITE. THE PT CLAIMED TO ONLY BE ABLE TO SEE THROUGH "A HOLE" IN HER RIGHT EYE. THE PT PARTIALLY RECOVERED WITH MINOR RESIDUALS. THE NEUROLOGICAL DEFICIT WAS DOCUMENTED AS PERMANENT. THE PROD IS NOT AVAILABLE FOR EVAL AND TESTING. ADD'L INFO TO BE SUBMITTED 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG REPORT #1016427-2008-00148 AND 9616099-2008-01341.

    Description of Event or Problem · 1

    AFTER POST-DILATION OF THE CAROTID STENT, THE PT STARTED COMPLAINING OF VISION PROBLEMS WITH THE RIGHT EYE. THE PHYSICIAN BELIEVES THAT THE PT SUFFERED A SMALL EMBOLIC EVENT DURING THE PROCEDURE. IT WAS ALSO NOTED THAT NIGHT, AFTER THE PROCEDURE, THE PT SUFFERED A BLEED. THE TYPE OF BLEED IS UNK. THE PT IS A FEMALE PT WAS CONSENTED TO THE STUDY IN 2008. THE INDEX PROCEDURE WAS COMPLETED ON THREE DAYS LATER, AND PT WAS SYMPTOMATIC. THE TARGET LESION LOCATION WAS THE RIGHT INTERNAL CAROTID ARTERY. THERE WAS NO OCCLUSION IN THE CONTRALATERAL CAROTID. THE CHARACTERISTICS OF THE VESSEL ARE UNK. THE PHYSICIAN MADE ACCESS TO THE PT IN THE RIGHT FEMORAL ARTERY. AFTER PERFORMING AN ARCH AORTAGRAM AND BILATERAL SELECTIVE CAROTID ANGIOGRAMS, AN ANGIOGUARD DISTAL PROTECTION DEVICE WAS ADVANCED OVER A .038 ANGLED GLIDEWIRE, DISTAL TO THE TARGET LESION. AT THIS POINT, THE PT HAD NORMAL SPEECH AND FACIAL EXPRESSION. THERE WAS ALSO NORMAL LIMB MOVEMENT. ATROPINE WAS GIVEN. THE DISTAL PROTECTION WAS DEPLOYED. PRE-DILATATION OF THE LESION WAS COMPLETED WITH A MAVERICK 2 RX 4X25 BALLOON AT 6 ATMOSPHERES (ATMS) FOR 12 SECONDS. THE BALLOON WAS REMOVED. A MANUALLY INJECTED RIGHT CAROTID ARTERY ANGIOGRAM WAS PERFORMED. A PRECISE STENT WAS SUCCESSFULLY DEPLOYED AND WAS POST-DILATED WITH A QUANTUM MAVERICK RX BALLOON AT 16 ATMS FOR 9 SECONDS. THE PT HAD NORMAL SPEECH AND FACIAL EXPRESSION. THERE WAS ALSO NORMAL LIMB MOVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R| S .038 ANGLED GLIDEWIRE| QUANTUM MAVERICK RX BALLOON 5X20| 5FR VTK-125CM (COOK)| MAVERICK 2 RX 4X25 BALLOON| 6FR SHUTTLE SHEATH