BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX

    MDR report key: 1071584 · Received July 7, 2008

    Report

    Report Number
    1016427-2008-00189
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 11, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS STUDY PT UNDERWENT RIGHT CAROTID ARTERY STENT IMPLANTATION AND EXPERIENCED HYPOTENSION AND STROKE AS EVIDENCED BY LEFT HEMIPARESIS. THE PT WAS A FEMALE WITH MEDICAL HISTORY INCLUDING POSITIVE CARDIAC STRESS TEST, KNOWN CORONARY ARTERY DISEASE AND CABG (CORONARY ARTERY BYPASS GRAFTING). THE TARGET LESION WAS RIGHT CAROTID ARTERY DESCRIBED AS SEVERELY TORTUOUS, ULCERATED, ECCENTRIC AND 80% STENOTIC. TWO ANGIOGUARD DEVICES WERE ATTEMPTED BUT MET DIFFICULTY SECONDARY TO THE TARGET VESSEL'S SEVERE TORTUOUSITY. AFTER THE FIRST FAILED ANGIOGUARD, THE PT BECAME HYPOTENSIVE, THIS WAS TREATED WITH NEO-SYNEPHRINE IV AND THE BLOOD PRESSURE RETURNED TO BASE LINE VALUES. A THIRD ANGIOGUARD WAS PLACED WITH MINIMAL DIFFICULTY AND THE PRECISE STENT WAS PLACED SUCCESSFULLY. DURING POST-DILATION OF THE STENT WITH AN AVIATOR BALLOON, THE PT EXPERIENCED A HEADACHE. THE BALLOON WAS REMOVED AND THE HEADACHE RESOLVED. THEN A SECOND, DIFFICULTLY SIZED, AVIATOR WAS INSERTED FOR FURTHER POST-DILATION. DURING INFLATION OF THIS BALLOON, THE PT AGAIN COMPLAINED OF HEADACHE AND THEN WAS UNABLE TO FOLLOW COMMANDS. THE BALLOON AND THE FILTER WERE REMOVED; AT THIS TIME THE PT WAS UNABLE TO MOVE HER LEFT ARM. THE PT HAD NEUROLOGICAL DEFICITS WHEN DISCHARGED FROM THE ANGIO SUITE AND WAS DIAGNOSED WITH AN ISCHEMIC STROKE. THE PT WAS MAINTAINED ON AN ASA AND PLAVIX MEDICATION REGIMEN FOR THE PROCEDURE AND POST OPERATIVELY. THE PT CONTINUES TO DISPLAY NEUROLOGICAL DEFICITS. THE STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THE PRODUCT WAS NOT RETURNED FOR EVAL. WITHOUT THE DEVICE INVOLVED AVAILABLE FOR EVAL, THE EXACT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THIS LOT WAS PERFORMED AND INDICATED THAT THIS PRODUCT WAS FINAL INSPECTION TESTED AND WAS DETERMINED TO BE ACCEPTABLE. HYPOTENSION AND ISCHEMIC STROKE ARE BOTH WELL-KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CAROTID ARTERY STENT IMPLANTATION. THE PHYSICAL MANIPULATION OF THE CAROTID ARTERY CAN AFFECT BLOOD PRESSURE, DISLODGE PLAQUE AND POSSIBLY EMBOLIZE DEBRIS DOWN STREAM INTO THE CEREBRAL CIRCULATION. THERE ARE VESSEL CHARACTERISTICS AND PROCEDURAL ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. SPECIFICALLY, THE TARGET VESSEL / LESION HAD SEVERE TORTUOUSITY THAT MAY HAVE CONTRIBUTED TO THE EVENTS EXPERIENCED. THE TORTUOSITY MAY HAVE ALSO CONTRIBUTED TO THE PROBLEMATIC TRACKING AND PLACEMENT OF THE ANGIOGUARD DEVICES. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF FOUR INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 1016427-2008-00188, 9610978-2008-00165, 9616099-2008-01679, AND 1016427-2008-00189.

    Description of Event or Problem · 1

    DURING A CAROTID STENTING PROCEDURE, THE PT BECAME HYPOTENSIVE AND COMPLAINED OF HEADACHES. THE PT WAS UNABLE TO MOVE HER LEFT ARM AFTER THE BALLOON AND ANGIOGUARD WERE REMOVED. THE PT WAS DIAGNOSED WITH AN ISCHEMIC STROKE. THE PT WAS A FEMALE WITH MEDICAL HISTORY INCLUDING POSITIVE CARDIAC STRESS TEST, KNOWN CORONARY ARTERY DISEASE AND CABG CORONARY ARTERY BYPASS (GRAFTING). THE TARGET LESION WAS RIGHT CAROTID ARTERY DESCRIBED AS SEVERELY TORTUOUS, ULCERATED, ECCENTRIC AND 80% STENOTIC. ACCESS WAS MADE IN THE COMMON FEMORAL ARTERY. A SHUTTLE SHEATH WAS ADVANCED INTO THE COMMON CAROTID ARTERY. AFTER A SELECTIVE ANGIOGRAM WAS PERFORMED, AN ANGIOGUARD FILTER WIRE WAS ADVANCED TO THE LESION. THERE WAS SOME DIFFICULTY ADVANCING THE DEVICE DUE TO THE TORTUOUSITY OF THE VESSEL. THE PHYSICIAN WAS UNABLE TO CROSS THE LESION WITH THE ANGIOGUARD AND THE PT BECAME HYPOTENSIVE, THIS WAS TREATED WITH NEO-SYNEPHRINE IV AND THE BLOOD PRESSURE RETURNED TO BASE LINE VALUES. A SECOND ANGIOGUARD WAS ADVANCED WITH THE SAME RESULT. A THIRD ANGIOGUARD WAS PLACED WITH MINIMAL DIFFICULTY. THE LESION WAS PRE-DILATED 4 MM AVIATOR BALLOON. A PRECISE STENT WAS PLACED AND A 5 MM AVIATOR BALLOON WAS USED FOR POST DILATION. AT THIS POINT, THE PT COMPLAINED OF HEADACHES. THE BALLOON WAS REMOVED AND THE HEADACHE RESOLVED. ANOTHER 4MM AVIATOR BALLOON WAS USED FOR ADDITIONAL POST-DILATION. DURING INFLATION OF THIS BALLOON, THE PT AGAIN COMPLAINED OF HEADACHE AND THEN WAS UNABLE TO FOLLOW COMMANDS. THE BALLOON AND THE FILTER WERE REMOVED; AT THIS TIME, THE PT WAS UNABLE TO MOVE HER LEFT ARM. THE PT HAD NEUROLOGICAL DEFICITS WHEN DISCHARGED FROM THE ANGIO SUITE AND WAS DIAGNOSED WITH AN ISCHEMIC STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70607502

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R