BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX

    MDR report key: 1221966 · Received November 3, 2008

    Report

    Report Number
    1016427-2008-00284
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    June 20, 2008
    Report Date
    October 28, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCEDURAL INFORMATION WAS NOTED AS THE FOLLOWING: TARGET LESION REFERENCE VESSEL DIAMETER WAS 4.5 AND DIAMETER STENOSIS WAS 99.0 WITH LESION LENGTH 29.5. TOTAL LENGTH OF STENTED SEGMENT WAS 40.0. ARCH TYPE WAS II AND SEVERE LESION CALCIFICATION AND MILD VESSEL TORTUOSITY. ADDITIONALLY, THERE WAS OCCLUSION IN CONTRALATERAL CAROTID. THE LESION WAS PREDILATED WITH NO RESISTANCE TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DOCUMENTED. AN ANGIOGUARD RX DISTAL PROTECTION DEVICE WAS SUCCESSFULLY PLACED AND THE PRECISE PRO RX STENT WAS IMPLANTED FOR TREATMENT OF TARGET LESION. FINAL TARGET LESION PERCENT DIAMETER STENOSIS WAS 0. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AND TESTING. HOWEVER, ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO DEVICES INVOLVED WITH THIS REPORTED EVENT, WHICH IS ASSOCIATED WITH MFG REPORT NUMBER: 9616099-2008-02587.

    Description of Event or Problem · 1

    THE PATIENT WAS CONSENTED IN THE STUDY, AND THE PROCEDURE WAS COMPLETED DAY AFTER CONSENT. THE TARGET LESION WAS LOCATED IN THE RIGHT MID INTERNAL CAROTID ARTERY WITH OCCLUSION IN CONTRALATERAL CAROTID. DURING THE CAROTID STENTING, THERE WAS SLOW TO NO FLOW AFTER STENT DEPLOYMENT (WHICH HAS BEEN CODED AS "OTHER" UNDER F10 PATIENT CODES) AND THE PATIENT BECAME UNRESPONSIVE. FLOW THROUGH THE STENT DID RECONSTITUTE. THE PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT WHERE MRI SHOWED DIFFUSE SIGNAL HYPER-INTENSITY IN THE RIGHT FRONTAL AND PARIETAL LOBES CONSISTENT WITH A SUBARACHNOID HEMORRHAGE. ASPIRIN, PLAVIX AND DEEP VEIN THROMBOSIS PROPHYLAXIS WERE DISCONTINUED, AND NIMODIPINE WAS INITIATED. PER DISCHARGE SUMMARY, DURING THE TIME OF THE STROKE, THE PATIENT EXPERIENCED SEIZURES THAT WERE TREATED WITH DEPAKOTE. FOLLOWING THE STROKE, THE PATIENT EXPERIENCED FEVER AND LEUKOCYTOSIS THAT WERE FELT TO BE RELATED TO NEUROLOGICAL INJURY. THE PATIENT WAS TREATED WITH VANCOMYCIN AND INTRAVENOUS AVELOX AND WAS DISCHARGED FIVE DAYS LATER. AT DISCHARGE, THE PATIENT WAS MOVING LEFT UPPER EXTREMITY, AND IT APPEARED TO HAVE DIFFICULTY WITH SPEECH AND WITH SWALLOWING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLIC PROTECTION DEVICE NTE CORDIS CORPORATION NA 70508504

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Life Threatening| H ATROPINE| AVELOX | GENEDRYL| HEPARIN| NTG| HEPARIN| ATROPINE| NTG| AVELOX| GENEDRYL