BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX

    MDR report key: 1071593 · Received July 8, 2008

    Report

    Report Number
    1016427-2008-00191
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 19, 2008
    Report Date
    June 25, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING POST-DILATION, THE PATIENT SUFFERED AN EPISODE OF SEVERE BRADYCARDIA, WHICH SPONTANEOUSLY RESOLVED, BUT WAS TREATED WITH ATROPINE BY THE ANESTHESIA TEAM. THE PATIENT IS A MALE WITH A HISTORY OF TRANSIENT ISCHEMIC ATTACKS (TIA). THE PATIENT WAS ENROLLED IN THE SAPPHIRE STUDY. THE TARGET LESION WAS THE BIFURCATION OF THE RIGHT CAROTID ARTERY. THE VESSEL WAS DESCRIBED AS AN ULCERATED ECCENTRIC LESION WITH MODERATE CALCIFICATION. THE RATE OF STENOSIS WAS 54%. THE PHYSICIAN MADE ACCESS TO THE PATIENT FROM THE RIGHT GROIN. AFTER SELECTIVE ANGIOGRAPHY WAS PERFORMED, A 6FR. SHUTTLE SHEATH WAS POSITIONED IN THE DISTAL RIGHT COMMON CAROTID ARTERY BUT PROXIMAL TO THE STENOSIS. AN ANGIOGUARD DISTAL PROTECTION DEVICE WAS ADVANCED AND POSITIONED IN THE MID PORTION OF THE RIGHT INTERNAL CAROTID ARTERY (ICA), DISTAL TO THE LESION. AN 8MM PRECISE STENT WAS POSITIONED AND DEPLOYED FROM THE PROXIMAL RIGHT ICA THROUGH THE BIFURCATION TO THE DISTAL RIGHT COMMON CAROTID. THE STENT WAS THEN POST-DILATED WITH A 7MM BALLOON (BRAND UNKNOWN). THE FIRST BALLOON INFLATION RESULTED IN SEVERE BRADYCARDIA THAT SPONTANEOUSLY RESOLVED. THE PATIENT WAS STILL ADMINISTERED ATROPINE IV. BLOOD PRESSURE REMAINED STABLE AND HEART RATE RETURNED TO NORMAL. ANOTHER INFLATION OF THE BALLOON WAS PERFORMED WITH GOOD RESULT. THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT. THE DISTAL PROTECTION DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED. POST PROCEDURE, ANGIOGRAPHY GOOD RESULT WITH A RESIDUAL 20% STENOSIS. THE PATIENT WAS NEUROLOGICALLY INTACT WHEN TAKEN FROM THE ANGIO SUITE. THE NEXT MORNING, THE PATIENT DEVELOPED SOME DIFFICULTY WITH EXPRESSIVE APHASIA. AN MRI OF THE BRAIN SHOWED SOME SMALL, SCATTERED DIFFUSION CONSISTENT WITH ISCHEMIA DISTRIBUTED THROUGHOUT THE LEFT PARIETAL/SUBCORTICAL REGION. NIH STROKE SCALE WAS AT 2 AND THE PATIENT HAD ALREADY BEEN ON ANTIPLATELET THERAPY, NO FURTHER INTERVENTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 71206505

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R PRECISE STENT| 7X20 BALLOON| SHUTTLE SHEATH