BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 2854121 · Received December 3, 2012

    Report

    Report Number
    1016427-2012-00146
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 7, 2012
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDENDUM: BASED ON THE (B)(6) STUDY ADJUDICATION MINUTES, THE COMMITTEE HAS DETERMINED THAT THE PATIENT EXPERIENCED A CVA-EMBOLIC. THE EVENT HAD BEEN PREVIOUSLY REPORTED AS A TIA. UPDATED COMPLAINT CONCLUSION: BASED ON THE CEC SAPPHIRE STUDY ADJUDICATION MINUTES, THE COMMITTEE HAS DETERMINED THAT THE PATIENT EXPERIENCED A CVA-EMBOLIC ON (B)(6) 2012. IT WAS REPORTED AS RELATED TO THE INDEX PROCEDURE AND RELATED TO THE STUDY DEVICE. THE EVENT HAD BEEN PREVIOUSLY CAPTURED IN THE FILE AS A TIA. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 80% STENOS IS IN THE OSTIUM RIGHT INTERNAL CAROTID ARTERY AND IN THE BIFURCATION OF THE RIGHT COMMON CAROTID ARTERY. PRE-PROCEDURE NIH STROKE SCALE SCORE WAS 1 AND THE PATIENT WAS ASYMPTOMATIC (DECREASED VISION IN THE LEFT EYE). THE LESION WAS DESCRIBED AS 25MM IN LENGTH, CONCENTRIC, ARCH TYPE III, MILD TORTUOUSITY AND ECCENTRIC. A 6MM ANGIOGUARD WAS DEPLOYED BEYOND THE TARGET LESION WITHOUT ANY DIFFICULTIES REPORTED. THE LESION WAS PRE-DILATED FOLLOWED BY DEPLOYMENT OF AN 8.0 X 40MM PRECISE PRO WITH A 20% STENOSIS. THE PATIENT EXPERIENCED AN EMBOLIC STROKE AFTER THE REMOVAL OF THE ANGIOGUARD DEVICE. NO AIR BUBBLES WERE NOTED DURING THE PROCEDURE. IT WAS NOTED THAT THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH PERMANENT BEHAVIORAL CHANGES AND LEFT HEMIPARESIS. THE PATIENT'S MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA, CARDIAC ARRHYTHMIA, CONGESTIVE HEART FAILURE, RENAL INSUFFICIENCY, HISTORY OF SMOKING, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, CORONARY PERCUTANEOUS REVASCULARIZATION AND HYPERTENSION WITH HIGH RISK CRITERIA OF DIALYSIS-DEPENDENT RENAL FAILURE. (B)(4): THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. 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. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, PHARMACEUTICAL, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED VIA THE SAPPHIRE REGISTRY, A PATIENT EXPERIENCED AN ISCHEMIC STROKE DURING THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 80% STENOS IS IN THE OSTIAL RIGHT INTERNAL CAROTID ARTERY AND THE BIFURCATION OF THE RIGHT COMMON CAROTID ARTERY. PRE-PROCEDURE NIH STROKE SCALE SCORE WAS 1 AND THE PATIENT WAS ASYMPTOMATIC (DECREASED VISION IN THE LEFT EYE). THE LESION WAS DESCRIBED AS 25MM IN LENGTH, CONCENTRIC, ARCH TYPE III, MILD TORTUOUSITY AND ECCENTRIC. A 6MM ANGIOGUARD WAS DEPLOYED BEYOND THE TARGET LESION WITHOUT ANY DIFFICULTIES REPORTED. THE LESION WAS PRE-DILATED FOLLOWED BY DEPLOYMENT OF AN 8.0 X 40MM PRECISE PRO WITH A 20% STENOSIS. THE PATIENT EXPERIENCED AN ISCHEMIC STROKE DURING THE REMOVAL OF THE ANGIOGUARD DEVICE. NO AIR BUBBLES WERE NOTED DURING THE PROCEDURE. IT WAS NOTED THAT THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH PERMANENT BEHAVIORAL CHANGES AND LEFT HEMIPARESIS. THE PATIENT'S MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA, CARDIAC ARRHYTHMIA, CONGESTIVE HEART FAILURE, RENAL INSUFFICIENCY, HISTORY OF SMOKING, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, CORONARY PERCUTANEOUS REVASCULARIZATION AND HYPERTENSION WITH HIGH RISK CRITERIA OF DIALYSIS-DEPENDENT RENAL FAILURE. THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING ROUTE SHEETS WAS NOT PERFORMED SINCE A VALID LOT NUMBER WAS NOT PROVIDED. STROKE IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND IS LISTED IN THE IFU AS SUCH. IT 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. 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; 80% 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2012-00714 AND 1016427-2012-00146

    Description of Event or Problem · 1

    AS REPORTED VIA THE SAPPHIRE REGISTRY, A PATIENT EXPERIENCED AN ISCHEMIC STROKE DURING THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 80% STENOS IS IN THE OSTIAL RIGHT INTERNAL CERATOID ARTERY AND THE BIFURCATION RIGHT COMMON ARTERY. PRE-PROCEDURE NIH STROKE SCALE SCORE WAS 1 AND THE PATIENT WAS ASYMPTOMATIC (DECREASED VISION IN THE LEFT EYE). THE LESION WAS DESCRIBED AS 25MM IN LENGTH, CONCENTRIC, ARCH TYPE III, MILD TORTUOSITY AND ECCENTRIC. THE REFERENCE VESSEL WAS REPORTED AS UNKNOWN. A 6MM ANGIOGUARD WAS DEPLOYED BEYOND THE TARGET LESION WITHOUT ANY DIFFICULTIES REPORTED. THE LESION WAS PRE-DILATED WITH A 8.0 X 40MM PRECISE PRO RX AT THE TARGET LESION. THERE WAS 20% OF RESIDUAL STENOSIS. THE PATIENT EXPERIENCED AN ISCHEMIC STROKE DURING THE REMOVAL OF THE ANGIOGUARD DEVICE. NO AIR BUBBLES WERE NOTED DURING THE PROCEDURE. IT WAS NOTED THAT THE PATIENT HAD PERMANENT BEHAVIORAL CHANGES WITH LEFT HEMIPARESIS. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NEUROLOGICAL DEFICITS. THE PATIENT HAD DIAGNOSTIC HEAD CT AND RECEIVED HEPARIN GTT. PER THE INVESTIGATOR, THE EVENT WAS RELATED TO THE INDEX PROCEDURE. THEN, THREE DAYS LATER THE PATIENT HAD A SUDDEN DEATH. THE DEATH WAS CLASSIFIED AS A CARDIAC TYPE CAUSED BY CONGESTIVE HEART FAILURE. PER THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO THE INDEX PROCEDURE OR THE CORDIS DEVICE. HOWEVER, NOTED THAT THE EVENT WAS RELATED TO RECEIVING CAROTID STENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death