BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX

    MDR report key: 1063210 · Received June 17, 2008

    Report

    Report Number
    1016427-2008-00173
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 29, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRECISE STENT WAS IMPLANTED FOR TREATMENT OF TARGET LESION. DURING STENT PLACEMENT, THERE WAS A MILD AIR BUBBLE AND TOTAL OCCLUSION OF FLOW INTO THE LEFT INTERNAL CAROTID DUE TO THE STENT APPARATUS. AFTER THE PROCEDURE, THE PHYSICIAN STATED THAT AIR IN THE SHUTTLE SHEATH DURING STENT DELIVERY. THE STENT WAS SUCCESSFULLY DEPLOYED. POST DILATION WAS PERFORMED WITH A 5.5 MM AVIATOR BALLOON. AFTER STENT PLACEMENT, THE PT BECAME RESTLESS AND COULD NOT FOLLOW COMMANDS. THE PT ALSO SUFFERED FACIAL DROOP, AND RIGHT-SIDED WEAKNESS, WHICH RESOLVED BY THE TIME THE PT LEFT THE ANGIO SUITE. THE ANGIOGUARD WAS REMOVED AND REPEAT ANGIOGRAPHY SHOWED THE 85% STENOSIS WAS REDUCED TO LUMINAL IRREGULARITIES WITH OUTSTANDING RESULTS. THE PT WAS DISCHARGED THE NEXT DAY. THE PROD IS NOT AVAILABLE FOR EVAL AND TESTING. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG REPORT # 9616099-2008-01531 AND 1016427-2008-00173.

    Description of Event or Problem · 1

    AFTER PRE-DILATION OF THE LESION THE PT WENT INTO BRADYCARDIA AND WAS TREATED WITH ATROPINE. DURING STENT PLACEMENT, THERE WAS A MILD AIR BUBBLE AND TOTAL OCCLUSION OF FLOW INTO THE LEFT INTERNAL CAROTID. THE PT ALSO SUFFERED FACIAL DROOP, RIGHT-SIDED WEAKNESS, AND AN INABILITY TO FOLLOW COMMANDS DURING THE PROCEDURE AND WAS DIAGNOSED WITH A TRANSIENT ISCHEMIC ATTACK. THE PT IS A MALE PT WHO WAS ENROLLED IN THE STUDY. THE INDEX PROCEDURE WAS COMPLETED IN 2008, AND PT WAS ASYMPTOMATIC. THE TARGET LESION LOCATION WAS THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY ( ICA). THERE WAS NO OCCLUSION IN THE CONTRALATERAL CAROTID. THE VESSEL HAD A SEVERE PROXIMAL 85% STENOSIS. THE REST OF THE INTERNAL CAROTID WAS FREE OF SIGNIFICANT DISEASE. THE PHYSICIAN MADE ACCESS IN THE RIGHT GROIN. AFTER PERFORMING ARCH ANGIOGRAPHY AND CEREBRAL ANGIOGRAPHY, THE PHYSICIAN WIRED THE LEFT EXTERNAL CAROTID AND A 6FR. COOK SHUTTLE SHEATH WAS ADVANCED AND PLACED INTO THE LEFT COMMON CAROTID ARTERY. AN ANGIOGUARD DISTAL PROTECTION DEVICE WAS THEN PLACED INTO THE LEFT MID ICA. THE LEFT ICA WAS PRE-DILATED WITH A 4X30 AVIATOR BALLOON. DURING PRE-DILATION OF THE LESION, THE PT HAD DIFFICULTY RESPONDING TO QUESTIONS AND GARBLED SPEECH. THE BALLOON WAS REMOVED. THE PT WAS GIVEN .5MG OF ATROPINE IV, AS THERE WAS AN INDICATION THAT THE PT HAD BRADYCARDIA. THE PT HAD A GOOD RESPONSE TO THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70407503

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R 6FR SHUTTLE SHEATH