BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1884180 · Received October 27, 2010

    Report

    Report Number
    1016427-2010-00131
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 6, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE (B)(4) REGISTRY DURING POST-DILATION OF THE PRECISE CAROTID STENT THE PATIENT SUFFERED SOME EXPRESSIVE APHASIA AND WAS DIAGNOSED WITH A TRANSIENT ISCHEMIC ATTACK (TIA). INTEGRILIN BOLUS AND DRIP WAS ADMINISTERED WITH FULL RECOVERY/NO RESIDUAL. IT WAS REPORTED THAT IT WAS FELT THAT THE ADVERSE EVENT WAS NOT RELATED TO THE STENT OR ANGIOGUARD DEVICE. AT BASELINE THE PATIENT'S HISTORY INCLUDED SEVERE PULMONARY DISEASE, HYPERLIPIDEMIA, RENAL INSUFFICIENCY, HISTORY OF SMOKING, CORONARY ARTERY DISEASE, AND HYPERTENSION. THE PATIENT WAS HIGH RISK FOR ENDARTERECTOMY DUE TO PRIOR RADIATION THERAPY FOR MALIGNANCY. THE PATIENT UNDERWENT LEFT CAROTID ARTERY STENTING TREATING A HIGH GRADE SYMPTOMATIC LEFT INTERNAL CAROTID ARTERY (ICA) STENOSIS. PRE-PROCEDURE STROKE SCALE EXAMINATIONS REVEALED EVIDENCE OF AN OLD STROKE WITH RIGHT-SIDED HEMIPARESIS AND LEG WEAKNESS. NIH STROKE SCORE WAS 2 AND MODIFIED RANKIN SCORE WAS 1. THE 80% LEFT PROXIMAL INTERNAL CAROTID ARTERY LESION WAS 10MM IN LENGTH AND HAD MILD CALCIFICATION. REFERENCE DIAMETER WAS 6.0MM. THE LESION WAS PRE-DILATED WITH A 3MM SLEEK BALLOON WITH NO DOCUMENTED RESISTANCE. AN 8X40 PRECISE STENT WAS SUCCESSFULLY PLACED AT THE LESION AND POST-DILATED WITH A 5X30MM AVIATOR BALLOON. THERE WAS EXCELLENT RESULT WITH NO RESIDUAL STENOSIS AND NO FILLING DEFECTS. THE FINAL TARGET LESION STENOSIS WAS 0%. THERE WAS RAPID FLOW THROUGH THE FILTER. IT WAS NOTED THAT DURING POST-DILATION THE PATIENT DEVELOPED EXPRESSIVE APHASIA WHICH GOT BETTER DURING THE REMAINDER OF THE PROCEDURE. FURTHER IMAGING WAS PERFORMED OF THE STENT AND THE BRAIN AND NO SPECIFIC ABNORMALITIES WERE NOTED. THE FILTER BASKET WAS RECAPTURED. THE SHEATH WAS WITHDRAWN BACK TO THE IPSILATERAL SIDE AND EXCHANGED FOR A SHORTER 7-FR SHEATH. THE PATIENT WAS GIVEN A SINGLE BOLUS OF INTEGRILIN AND WAS TREATED WITH AN INTEGRILIN DRIP FOR 6 HOURS POST-PROCEDURE. THE PATIENT WAS STILL ABLE TO FOLLOW COMMANDS AND THERE WAS NO EVIDENCE OF HEAD/EYE DEVIATION. THE PATIENT WAS DIAGNOSED WITH A TRANSIENT ISCHEMIC ATTACK (TIA). UPON COMPLETION OF THE STUDY, THE PATIENT'S SYMPTOMS HAD SEEMED TO RESOLVE. A NEUROLOGIST EXAMINED THE PATIENT POST-PROCEDURE AND REVEALED THAT THE PATIENT WAS BACK TO BASELINE. IT WAS NOTED THAT THE PATIENT WAS TREATED PER PROCEDURE WITH PLAVIX AND ASPIRIN, AND WAS TREATED DURING THE PROCEDURE WITH HEPARIN AND INTEGRILIN. THE PATIENT WAS GIVEN 5000U OF HEPARIN AFTER CATHETERIZATION OF THE FEMORAL ARTERY. AN ACT WAS OBTAINED AFTER PLACEMENT OF THE CAROTID SHEATH AND WAS MEASURED AT 204. THE PATIENT WAS THEN GIVEN 2500U OF HEPARIN FOR A TOTAL OF 7500. NEAR THE COMPLETION OF THE PROCEDURE, THE ACT WAS MEASURED AT 275. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. TIA IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CAROTID ARTERY STENTING PROCEDURE AS LISTED IN THE INSTRUCTIONS FOR USE. IT IS ASSOCIATED WITH A STOPPAGE OR SLOWING OF BLOOD FLOW TO THE CEREBRAL ARTERIES. DURING INTERVENTIONAL PROCEDURES, THE DEVICES ARE ADVANCED AND WITHDRAWN THROUGH ACCESSORY ARTERIES TO TREAT THE TARGET LESION AND BLOOD FLOW IS TEMPORARILY BLOCKED DURING BALLOON INFLATION. 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. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL / LESION CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO EVIDENCE THAT DEVICE PERFORMANCE OR MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF THREE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFR REPORTS # 9610978-2010-00217, 1016427-2010-00131, AND 9616099-2010-00819.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS STILL ABLE TO FOLLOW COMMANDS AND THERE WAS NO EVIDENCE OF HEAD/EYE DEVIATION. THE PATIENT WAS DIAGNOSED WITH A TRANSIENT ISCHEMIC ATTACK (TIA). UPON COMPLETION OF THE STUDY THE PATIENT'S SYMPTOMS HAD SEEMED TO RESOLVED. A NEUROLOGIST EXAMINED THE PATIENT POST-PROCEDURE AND REVEALED THAT THE PATIENT WAS BACK TO BASELINE. IT WAS NOTED THAT THE PATIENT WAS TREATED PRE PROCEDURE WITH PLAVIX AND ASPIRIN, AND WAS TREATED DURING THE PROCEDURE WITH HEPARIN AND INTEGRILIN. THE PATIENT WAS GIVEN 5000U OF HEPARIN AFTER CATHETERIZATION OF THE FEMORAL ARTERY. AN ACT WAS OBTAINED AFTER PLACEMENT OF THE CAROTID SHEATH AND WAS MEASURED AT 204. THE PATIENT WAS THEN GIVEN 2500U OF HEPARIN FOR A TOTAL OF 7500. NEAR THE COMPLETION OF THE PROCEDURE, THE ACT WAS MEASURED AT 275. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF THREE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9610978-2010-00217, 1016427-2010-00131, AND 9616099-2010-00819

    Description of Event or Problem · 1

    DURING POST-DILATION OF THE PRECISE CAROTID STENT THE PATIENT SUFFERED SOME EXPRESSIVE APHASIA AND WAS DIAGNOSED WITH A TRANSIENT ISCHEMIC ATTACK (TIA). THIS PATIENT WHO WAS ENROLLED IN THE SAPPHIRE STUDY UNDERWENT LEFT CAROTID ARTERY STENTING TREATING A HIGH GRADE SYMPTOMATIC LEFT INTERNAL CAROTID ARTERY (ICA) STENOSIS. PRE-PROCEDURE STROKE SCALE EXAMINATIONS REVEALED EVIDENCE OF AN OLD STROKE WITH RIGHT-SIDED HEMIPARESIS AND LEG WEAKNESS. A 6FR. DESTINATION SHEATH WAS INSERTED INTO THE DISTAL COMMON CAROTID ARTERY AND A 6FR ANGIOGUARD FILTER WAS ADVANCED ACROSS THE LESION AND PLACED AT THE BASE OF THE SKULL. THE LESION WAS PRE-DILATED WITH A 3MM SLEEK BALLOON. A PRECISE STENT WAS SUCCESSFULLY PLACED AT THE LESION AND POST-DILATED WITH A 5X30MM AVIATOR BALLOON. THERE WAS EXCELLENT RESULT WITH NO RESIDUAL STENOSIS AND NO FILLING DEFECTS. THERE WAS RAPID FLOW THROUGH THE FILTER. IT WAS NOTED THAT DURING POST-DILATION THE PATIENT DEVELOPED EXPRESSIVE APHASIA WHICH GOT BETTER DURING THE REMAINDER OF THE PROCEDURE. THE FILTER BASKET WAS RECAPTURED. THE SHEATH WAS WITHDRAWN BACK TO THE IPSILATERAL SIDE AND EXCHANGED FOR A SHORTER 7-FR SHEATH. THE PATIENT WAS GIVEN A SINGLE BOLUS OF INTEGRILIN AND WAS TREATED WITH AN INTEGRILIN DRIP FOR 6 HOURS POST-PROCEDURE.

    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 71009515

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R PRECISE STENT, 5X30MM AVIATOR BALLOON