BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOGUARD EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 3951964 · Received July 23, 2014

    Report

    Report Number
    1016427-2014-00081
    Event Type
    Death
    Date Received
    July 23, 2014
    Date of Event
    November 11, 2011
    Report Date
    July 3, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CONFERENCE ABSTRACT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW OF THIS DEVICE. THE CITATION IS AS FOLLOWS: SUGIU K., TOKUNAGA K., OHKUMA Y (2011, NOVEMBER 11), SELECTION OF EMBOLIC PROTECTION DEVICE IN CAROTID ARTERY STENTING (CAS)- USEFULNESS OF PLAQUE MR IMAGING. INTERVENTIONAL NEURORADIOLOGY, 17, 122. ONE MDR REPORT IS BEING SUBMITTED FOR ONE PATIENT WITH NO PATIENT DEMOGRAPHICS OR DEVICE SPECIFICS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 1016427-2014-00080 & 1016427-2014-00081. THIS IS THE INITIAL AND FINAL REPORT FOR THIS DEVICE. COMPLAINT CONCLUSION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. EMBOLIC STROKE IS A WELL DOCUMENTED POTENTIAL COMPLICATION OF CAROTID ARTERY INTERVENTIONS AND IS LISTED IN THE IFU AS SUCH. EMBOLIC STROKES ARE USUALLY CAUSED BY AN EMBOLUS (A BLOOD CLOT THAT FORMS ELSEWHERE IN THE BODY AND TRAVELS THROUGH THE BLOODSTREAM TO THE BRAIN) THAT TRAVELS FROM OTHER PARTS OF THE BODY TO THE NECK OR BRAIN AND BLOCKS A BLOOD VESSEL. EMBOLIC STROKES OFTEN RESULT FROM HEART DISEASE OR HEART SURGERY AND OCCUR RAPIDLY AND WITHOUT ANY WARNING SIGNS. ABOUT 15 PERCENT OF EMBOLIC STROKES OCCUR IN PEOPLE WITH ATRIAL FIBRILLATION. WHEN A CLOT FORMS IN A BLOOD VESSEL IN THE BRAIN OR NECK, IT IS CALLED A THROMBOTIC STROKE. EMBOLIC AND THROMBOTIC STROKES ARE CATEGORIZED AS ISCHEMIC STROKE. BASAL GANGLIA HEMATOMA: BASAL GANGLIA HEMATOMA IS A COLLECTION OF BLOOD AT THE BASE OF THE BRAIN IN AN AREA CALLED THE BASAL GANGLIA. THE FOLLOWING MEDICAL CONDITIONS ARE SOME OF THE POSSIBLE CAUSES OF BASAL GANGLIA HEMATOMA: STROKE, INTRACRANIAL HEMORRHAGE, AND SEVERE HYPERTENSION. INTRACEREBRAL HEMORRHAGE OCCURS WHEN A DISEASED BLOOD VESSEL WITHIN THE BRAIN BURSTS, ALLOWING BLOOD TO LEAK INSIDE THE BRAIN. THE SUDDEN INCREASE IN PRESSURE WITHIN THE BRAIN CAN CAUSE DAMAGE TO THE BRAIN CELLS SURROUNDING THE BLOOD. IF THE AMOUNT OF BLOOD INCREASES RAPIDLY, THE SUDDEN BUILDUP IN PRESSURE CAN LEAD TO UNCONSCIOUSNESS OR DEATH. INTRACEREBRAL HEMORRHAGE USUALLY OCCURS IN SELECTED PARTS OF THE BRAIN, INCLUDING THE BASAL GANGLIA, CEREBELLUM, BRAINSTEM, OR CORTEX. THE MOST COMMON CAUSE OF INTRACEREBRAL HEMORRHAGE IS HIGH BLOOD PRESSURE (HYPERTENSION). AFTER REVASCULARIZATION THAT ALLEVIATES A HIGH-GRADE SYMPTOMATIC STENOTIC LESION, CEREBRAL HYPERPERFUSION MAY OCCUR AS A RESULT OF A SUDDEN, RAPID INCREASE IN CEREBRAL BLOOD FLOW EXCESS OF THAT REQUIRED TO MEET METABOLIC DEMANDS. ANTICOAGULATION IS A KNOWN RISK FACTOR FOR BRAIN HEMORRHAGE IN PATIENTS WITH PRE-EXISTING DISEASE. LESS COMMON CAUSES OF INTRACEREBRAL HEMORRHAGE INCLUDE TRAUMA, INFECTIONS, TUMORS, BLOOD CLOTTING DEFICIENCIES, AND ABNORMALITIES IN BLOOD VESSELS (SUCH AS ARTERIOVENOUS MALFORMATIONS). TYPICALLY, INTRACEREBRAL HEMORRHAGE DEVELOPS ON THE THIRD TO FIFTH POST PROCEDURE DAY, THOUGH THERE HAVE BEEN CASES OBSERVED IMMEDIATELY AFTER SURGERY, AS WELL AS CASES DEVELOPED 3 WEEKS AFTER REVASCULARIZATION. NO ADDITIONAL PATIENT, LESION/VESSEL OR PROCEDURAL INFORMATION IS AVAILABLE. AT THIS TIME THERE IS NOT ENOUGH INFORMATION TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY SUGIU ET AL SELECTION OF EMBOLIC PROTECTION DEVICE IN CAROTID ARTERY STENTING (CAS) - USEFULNESS OF PLAQUE MR IMAGING, INTERVENTIONAL NEURORADIOLOGY 17 (2011) 122; IN THE ANGIOGUARD GROUP, TWO PATIENTS SUFFERED FROM THROMBOEMBOLIC MINOR STROKES. ONE PATIENT DEVELOPED A FATAL HEMATOMA IN THE BASAL GANGLIA. THE PURPOSE OF THE STUDY IS TO COMPARE CLINICAL RESULTS OF PROTECTED CAS WITH THE USE OF DIFFERENT TYPES OF EMBOLIC PROTECTION DEVICE (EPD) AND TO DISCUSS APPROPRIATE SELECTION OF EPDS ACCORDING TO CAROTID ARTERY PLAQUE CHARACTERISTICS DIAGNOSED BY MRI. TWO HUNDRED AND FOUR PATIENTS TREATED BY CAS UNDER DISTAL PROTECTION WERE INCLUDED. GROUP 1 INCLUDED 85 PATIENTS TREATED WITH PERCUSURGE GUARDWIRE (GW). GROUP 2 INCLUDED 55 PATIENTS TREATED WITH ANGIOGUARD XP (AG). GROUP 3 INCLUDED 69 PATIENTS OF WHICH DIFFERENT TYPES OF EPD WERE SELECTED IN EACH PATIENT DUE TO PLAQUE CHARACTERISTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431522 ANGIOGUARD EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE NTE CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death