BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1891188 · Received November 4, 2010

    Report

    Report Number
    1016427-2010-00133
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    May 12, 2008
    Report Date
    October 12, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE PROCEDURE. THERE WAS A TIGHT SEAL BETWEEN THE STENT DELIVERY SYSTEM AND THE TUOHY BORST (HEMOSTASIS) VALVE OF THE SHEATH INTRODUCER/GUIDING CATHETER DURING ASPIRATION. THE USER DID NOT ASPIRATE PRIOR TO CONTRAST INJECTIONS. THERE WAS NO AIR BUBBLES NOTED AT ANY TIME DURING THE PROCEDURE. THERE WAS NO THROMBUS NOTED PRE-DEPLOYMENT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00849 AND 1016427-2010-00133. CONCOMITANT DEVICES INCLUDED A 5MM ANGIOGUARD XP. INFORMATION WAS RECEIVED FROM A JAPANESE ARTICLE IN THE JAPANESE JOURNAL OF NEUROSURGERY 18(6):458-463, 2009. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ISCHEMIC STROKE THE SAME DAY AS THE INDEX PROCEDURE. THE TARGET LESION WAS LOCATED IN THE LEFT INTERNAL CAROTID ARTERY (ICA). THE LESION WAS DESCRIBED AS 83% STENOSED. LESION CALCIFICATION AND VESSEL TORTUOSITY WERE UNKNOWN. THE REFERENCE VESSEL WAS 3.86MM IN DIAMETER. AN UNKNOWN 8FR SHEATH WAS USED VIA THE FEMORAL APPROACH. THE TARGET LESION WAS EASILY CROSSED WITH THE ANGIOGUARD XP AND DEPLOYED BEYOND THE TARGET LESION. PRE-DILATION WAS PERFORMED WITH AN UNKNOWN BALLOON CATHETER AT 6 ATMOSPHERES. A 9X40MM PRECISE STENT WAS SUCCESSFULLY IMPLANTED FROM THE INTERNAL ICA TO THE COMMON CAROTID ARTERY. POST-DILATION WAS CONDUCTED WITH AN UNKNOWN BALLOON CATHETER AT 10 ATMOSPHERES. AFTER POST-DILATION, THE PATIENT EXPERIENCED DEPRESSED MENTAL STATUS, GENERAL APHASIA, AND RIGHT-SIDED HEMIPARESIS. THERE WAS NO OCCLUSION OBSERVED AT THE STENTED SITE AND THERE WAS NORMAL FLOW. THE ANGIOGUARD XP WAS SUCCESSFULLY RETRIEVED WITH NO DEBRIS NOTED IN THE BASKET. AFTER RETRIEVAL OF THE ANGIOGUARD, AN ANGIOGRAM WAS PERFORMED CONFIRMING NO ACUTE INFARCT. A COMPUTED TOMOGRAPHY (CT) SCAN WAS NEGATIVE FOR ABNORMAL FINDINGS. NIH STROKE SCALE SCORE AFTER THE INDEX PROCEDURE WAS 14. EDARAVONE AND ARGATROBAN WERE ADMINISTERED FOR TREATMENT OF THE NEUROLOGICAL SYMPTOMS. THE PATIENT'S BLOOD PRESSURE WAS CONTROLLED WITH NICARDIPINE. THE DAY FOLLOWING THE INDEX PROCEDURE, THE PATIENT'S NEUROLOGICAL STATUS REMAINED UNCHANGED. A MAGNETIC RESONANCE IMAGING (MRI) REVEALED MANY SMALL INFARCTS IN THE LEFT FRONTAL AND PARIETAL LOBES. THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE. THE SYMPTOMS IMPROVED AND THE PATIENT WAS DISCHARGED 16 DAYS AFTER THE INDEX PROCEDURE WITHOUT ANY NEUROLOGICAL DEFICITS. THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE PROCEDURE. THERE WAS A TIGHT SEAL BETWEEN THE STENT DELIVERY SYSTEM AND THE TUOHY BORST (HEMOSTASIS) VALVE OF THE SHEATH INTRODUCER/GUIDING CATHETER DURING ASPIRATION. THE USER DID NOT ASPIRATE PRIOR TO CONTRAST INJECTIONS. THERE WAS NO AIR BUBBLES NOTED AT ANY TIME DURING THE PROCEDURE. THERE WAS NO THROMBUS NOTED PRE-DEPLOYMENT. MEDICAL HISTORY INCLUDES HYPERTENSION, HYPERLIPIDEMIA, AND DIABETES MELLITUS. THE PRODUCT (B)(4) WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE ROOT CAUSE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE PRODUCT (B)(4) WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE ROOT CAUSE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ISCHEMIC STROKE IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND CAN BE DEFINED AS A CEREBROVASCULAR DISORDER CAUSED BY DEPRIVATION OF BLOOD FLOW TO AN AREA OF THE BRAIN; GENERALLY AS A RESULT OF THROMBOSIS, EMBOLISM, OR REDUCED BLOOD PRESSURE. AS ENDORSED BY 2009 GUIDELINES FROM THE AMERICAN HEART ASSOCIATION AND AMERICAN STROKE ASSOCIATION (AHA/ASA) ISCHEMIC STROKE IS DEFINED AS AN INFRACTION OF CENTRAL NERVOUS SYSTEM TISSUE. THE ACT OF STENT EXPANSION OR POST-DILATATION, TO OPTIMALLY OPPOSE A CAROTID STENT TO THE VESSEL WALL, TEMPORARILY OBSTRUCTS BLOOD FLOW TO THE CEREBRAL ARTERIES (ISCHEMIC PROCESS). THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT MAY TRAVEL UPSTREAM TO THE CEREBRAL ARTERIES POTENTIALLY DISRUPTING PERFUSION. THIS ACT, INHERENT TO THE PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A BLOOD VESSEL THAT IS NOT BLOCKED, BUT IS EXTREMELY NARROWED, CAN ALSO CAUSE AN ISCHEMIC STROKE. THE BLOCKED OR NARROWED ARTERIES DEPRIVE BRAIN CELLS OF OXYGEN AND NUTRIENTS, LEADING TO NERVE CELL DEATH. EIGHTY PERCENT OF ALL STROKES ARE ISCHEMIC. DURING ISCHEMIC STROKE, DIMINISHED BLOOD FLOW INITIATES A SERIES OF EVENTS (CALLED ISCHEMIC CASCADE) THAT MAY RESULT IN ADDITIONAL, DELAYED DAMAGE TO BRAIN CELLS. EARLY MEDICAL INTERVENTION CAN HALT THIS PROCESS AND REDUCE THE RISK FOR IRREVERSIBLE COMPLICATIONS. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A JAPANESE ARTICLE IN THE JAPANESE JOURNAL OF NEUROSURGERY 18(6):458-463, 2009. THE PATIENT EXPERIENCED AN ISCHEMIC STROKE THE SAME DAY AS THE INDEX PROCEDURE. THE TARGET LESION WAS LOCATED IN THE LEFT INTERNAL CAROTID ARTERY (ICA). THE LESION WAS DESCRIBED AS 83% STENOSED. LESION CALCIFICATION AND VESSEL TORTUOSITY WERE UNKNOWN. THE REFERENCE VESSEL WAS 3.86MM IN DIAMETER. AN UNKNOWN 8FR SHEATH WAS USED VIA THE FEMORAL APPROACH. THE TARGET LESION WAS EASILY CROSSED WITH THE GUIDE WIRE OF THE ANGIOGUARD XP. THE 5MM ANGIOGUARD XP WAS DEPLOYED BEYOND THE TARGET LESION. PRE-DILATION WAS PERFORMED WITH AN UNKNOWN BALLOON CATHETER AT 6ATMS. A 9X40MM PRECISE STENT WAS SUCCESSFULLY IMPLANTED FROM THE INTERNAL ICA TO THE COMMON CAROTID ARTERY. POST-DILATION WAS CONDUCTED WITH AN UNKNOWN BALLOON CATHETER AT 10ATMS. AFTER POST-DILATION, THE PATIENT EXPERIENCED DEPRESSED MENTAL STATUS, GENERAL APHASIA, AND RIGHT-SIDED HEMIPARESIS. NO OCCLUSION WAS NOTED AT THE STENTED SITE AND NORMAL FLOW WAS OBSERVED. THE ANGIOGUARD XP WAS SUCCESSFULLY RETRIEVED WITH NO DEBRIS NOTED IN THE BASKET. AFTER RETRIEVAL OF THE ANGIOGUARD XP, AN ANGIOGRAM REVEALED NO ACUTE INFARCT. A COMPUTED TOMOGRAPHY (CT) SCAN WAS NEGATIVE FOR ABNORMAL FINDINGS. NIH STROKE SCALE SCORE AFTER THE INDEX PROCEDURE WAS 14. EDARAVONE AND ARGATROBAN WERE ADMINISTERED FOR TREATMENT OF THE NEUROLOGICAL SYMPTOMS. THE PATIENT'S BLOOD PRESSURE WAS CONTROLLED WITH NICARDIPINE. THE DAY FOLLOWING THE INDEX PROCEDURE, THE PATIENT'S NEUROLOGICAL STATUS REMAINED UNCHANGED. A MAGNETIC RESONANCE IMAGING (MRI) REVEALED MANY SMALL INFARCTS IN THE LEFT FRONTAL AND PARIETAL LOBES. THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE. THE SYMPTOMS IMPROVED AND THE PATIENT WAS DISCHARGED 16 DAYS AFTER THE INDEX PROCEDURE WITHOUT ANY NEUROLOGICAL DEFICITS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R