BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX

    MDR report key: 1033589 · Received April 23, 2008

    Report

    Report Number
    1016427-2008-00119
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 26, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS POINT, THE PROCEDURE WAS ABORTED AND THE FILTER WIRE WAS REMOVED. THERE WAS NO DEBRIS FOUND IN THE FILTER WIRE UPON ITS REMOVAL. A CATSCAN WAS PERFORMED, AND REVEALED NO BLEEDING. THE PT HAD RECEIVED ANGIOMAX FOR THE PROCEDURE. ACT WAS 200. WITHIN A HALF AN HOUR, THE PATIENT'S ACT WAS BELOW 200. THE PHYSICIAN THEN PROCEEDED WITH THE CAROTID STENTING PROCEDURE AND THE PT'S NEUROLOGICAL STATUS WAS CONTINUALLY IMPROVING. NIA SCALE AT PEAK WAS 9. THE PT WAS GIVEN INTRAVENOUS TPA, AND SUDDENLY HER NEUROLOGICAL STATUS IMPROVED. WITHIN THE NEXT TWELVE HOURS, THE PT WAS BACK TO NORMAL WITH NO RESIDUAL DEFICITS. AN MRA WAS PERFORMED THE FOLLOWING MORNING SHOWING THAT THE DISTAL MIDDLE CEREBRAL BRANCH WAS FULLY OPEN. THE PHYSICIAN STATES, THAT THE PT'S NEUROLOGICAL DEFICIT WAS MAINLY IN THE FORM OF A TRANSIENT ISCHEMIC ATTACK (TIA), WHICH RESOLVED COMPLETELY, WITH TREATMENT. THE PT WAS CONTINUED ON ASPIRIN AND PLAVIX, OBSERVED FOR 48 HOURS, AND DISCHARGED IN STABLE CONDITION. THERE WERE NO NEW NEUROLOGICAL DEFICITS OBSERVED. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFO TO BE SUBMITTED 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AFTER POSITIONING THE ANGIOGUARD DEVICE DISTAL TO THE LESION, THE PT STARTED TO HAVE SYMPTOMS OF TIA. THE PROCEDURE WAS ABORTED AND THE PT WAS GIVEN TPA. THE SYMPTOMS RESOLVED WITHIN 24 HOURS AND THE PT WAS RESCHEDULED FOR CAROTID ENDARTERECTOMY. THE PT IS A FEMALE WITH A HISTORY OF CORONARY ARTERY DISEASE, STATUS POST MULTIPLE CORONARY INTERVENTIONS FOR ACUTE CORONARY SYNDROME. THE PT HAD A HISTORY SUGGESTIVE TO UNSTABLE ANGINA. AFTER PERFORMING A DIAGNOSTIC CORONARY ANGIOGRAM, CAROTID STENTING WAS PERFORMED. A 6FR SHUTTLE SHEATH WAS PLACED IN THE DESCENDING THORACIC AORTA. THE LEFT COMMON CAROTID ARTERY WAS ACCESSED USING A JR4 CORONARY CATHETER. BECAUSE OF SIGNIFICANT TORTUOSITY IN THE LEFT COMMON CAROTID, A GLIDEWIRE AND THEN A STORK WIRE WERE PASSED THROUGH A QUICK-CROSS CATHETER AND A SHEATH WAS ADVANCED INTO THE LEFT COMMON CAROTID ARTERY, WITHOUT DIFFICULTY. THE LESION WAS THEN CROSSED WITH A 6FR. ANGIOGUARD FILTER WIRE AND DEPLOYED DISTAL TO THE LESION. WHEN THE PHYSICIAN WAS PREPARING TO ADVANCE THE STENT THROUGH THE SHEATH, IT WAS NOTICED THAT THE PT HAD BECOME INCOHERENT AND DYSPHASIC, AND APPEARED UNABLE TO FOLLOW COMMANDS. A NEUROLOGICAL EVALUATION REVEALED THAT THE PT HAD DEVELOPED A FOCAL NEUROLOGICAL DEFICIT, MAINLY IN THE FORM OF LANGUAGE DISABILITY, DYSPHASIA. AN ANGIOGRAM AT THIS POINT REVEALED A DISTAL MIDDLE CEREBAL BRANCH EMBOLIC OCCLUSION. THE PHYSICIAN FELT THAT THIS WAS MOST LIKELY THROMBUS, WHICH MAY HAVE BEEN PRESENT IN THE PLAQUE AND COULD HAVE BEEN DISLODGED BY THE FILTER WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70108530

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R JR4 CORONARY CATHETER| STORK WIRE| 6FR. SHUTTLE SHEATH