BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 3071347 · Received April 22, 2013

    Report

    Report Number
    1016427-2013-00049
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    November 16, 2006
    Report Date
    March 25, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE INDICATED THAT DURING THE USE OF AN UNKNOWN PRECISE STENT AND UNKNOWN ANGIOGUARD EMBOLIC PROTECTIVE DEVICE THE PATIENT DEVELOPED SPASM AROUND THE ANGIOGUARD, BECAME BRADYCARDIC AND UNRESPONSIVE AND ONCE THE DEVICE WAS REMOVED, THE PATIENT WAS NORMAL. A 5F SHEATH WAS PLACED AND A 5F UNKNOWN CATHETER WAS ADVANCED INITIALLY INTO THE RIGHT COMMON CAROTID ARTERY. THERE IS SELF-LIKE PLAQUE AT THE RIGHT INTERNAL CAROTID ORIGIN WHICH CONSTITUTES AN APPROXIMATELY 60% STENOSIS. THERE IS ULCERATION WITHIN THE PLAQUE. DISTALLY, THERE IS GOOD FLOW IN THE RIGHT INTERNAL CAROTID ARTERY; HOWEVER, THE RIGHT A1 SEGMENT IS SMALL CALIBER AND THE RIGHT ACA FLOW IS MAINLY FROM THE LEFT SIDE. RIGHT MCA IS UNREMARKABLE. AFTER THESE FINDINGS WERE MADE, CATHETER WAS BROUGHT BACK A D ADVANCED INTO THE LEFT COMMON CAROTID. INJECTIONS SHOWED SEVERE STENOSIS IN THE VICINITY OF 90%. THERE IS FOCAL PLAQUE AT THE LEFT ICA ORIGIN CONSTITUTING THE STENOTIC LESION. BEYOND THIS, LEFT INTERNAL CAROTID IS PATENT WITH ANTEGRADE FLOW AND THERE IS GOOD FLOW IN THE LEFT ACA AND MCA. THERE IS CROSS FILLING OF THE RIGHT ACA THROUGH THE LEFT SIDE. AFTER THESE FINDINGS WERE MADE AND CONFIRMED ON MULTIPLE PROJECTIONS, MEASUREMENTS WERE OBTAINED AND THE INTERNAL CAROTID WAS MEASURED TO BE 5.15MM. THE COMMON CAROTID WAS MEASURED TO BE 6MM. AT THIS POINT, THE UNKNOWN CATHETER WAS MANIPULATED INTO THE EXTERNAL CAROTID OVER A GLIDEWIRE AND UNDER ROADMAP GUIDANCE. THE GUIDEWIRE WAS EXCHANGED FOR A STIFF UNKNOWN WIRE AND THE CATHETER AND THE GROIN SHEATH WERE EXCHANGED FOR A SHUTTLE 6F SHEATH THAT WAS BROUGHT OVER THE WIRE INTO THE COMMON CAROTID. A ROADMAP WAS CREATED AND THE STENOTIC ICA ORIGIN WAS NEGOTIATED WITH THE ANGIOGUARD DISTAL PROTECTION SYSTEM. THE ANGIOGUARD FILTER WAS DEPLOYED IN THE MID CERVICAL CAROTID SEVERAL INCHES ABOVE THE STENOTIC AREA. THEN A PREDILATATION OF THE STENOTIC AREA WAS PERFORMED WITH A 3.5MM BALLOON. THE PATIENT TOLERATED THIS WITHOUT A PROBLEM AND INJECTION AFTER THE PREDILATATION SHOWED IMPROVEMENT IN THE AREA OF THE STENOSIS. SOME MILD VASOSPASM WAS SEEN AROUND THE DISTAL PROTECTION DEVICE; HOWEVER, THIS WAS NOT FLOW-LIMITING AT THIS TIME. THEN THE PRECISE STENT OF 8 X 30 MM WAS DEPLOYED IN THE AREA OF STENOSIS AND THE PATIENT TOLERATED THIS WITHOUT A PROBLEM AS WELL. SINCE SOME RESIDUAL STENOSIS REMAINED AT THE WAIST OF THE STENT A POST-DILATION WAS PERFORMED WITH A 5 MM BALLOON. AFTER THE POST-DILATION, THE PATIENT DEVELOPED BRADYCARDIA WHICH LASTED APPROXIMATELY 15 SECONDS AND WE TREATED THE BRADYCARDIA WITH .6 MG OF ATROPHINE INFUSION. THE PATIENT BECAME WEAK IN THE RIGHT UPPER EXTREMITY DURING THE BRADYCARDIA EPISODE THEN BRIEFLY RECOVERED AND THEN BECAME COMPLETELY UNRESPONSIVE FOR A SHORT PERIOD. INJECTION DURING THIS TIME SHOWED COMPLETE OCCLUSION OF THE INTERNAL CAROTID ABOVE THE STENT IN THE AREA OF THE ANGIOGUARD. THIS WAS PRESUMABLY FROM SEVERE VASOSPASM AT THE LEVEL OF THE ANGIOGUARD. WE RAPIDLY ADVANCED A 5F UNKNOWN CATHETER OVER THE EXISTING WIRE AND PERFORMED SUCTION OF ANY THROMBUS THAT MAY HAVE FORMED ABOVE THE STENT THROUGH THE GUIDE CATHETER. NO CLOTS WERE SEEN IN THE ASPIRATE. THEN THE GUIDE CATHETER WAS RAPIDLY REMOVED AND THE CAPTURE CATHETER OF THE ANGIOGUARD WAS ADVANCED AND THE ANGIOGUARD WAS CAPTURED AND REMOVED. AFTER REMOVAL OF THE ANGIOGUARD, INJECTION SHOWED SEVERE SPASM IN AN OTHERWISE PATENT INTERNAL CAROTID ARTERY. THE SPASM WAS AT THE LEVEL OF THE ANGIOGUARD AND SEVERAL INCHES ABOVE THE STENT WHICH APPEARED TO BE COMPLETELY PATENT AND NONSTENOTIC. APPROXIMATELY 600MG OF NITROGLYCERIN WAS INFUSED THROUGH THE UNKNOWN CATHETER INTO THE CAROTID ARTERY AND THIS RESULTED IN COMPLETE RESOLUTION OF FLOW WITH NO RESIDUAL SPASM AND EXCELLENT RADIOGRAPHIC RESULTS. THE PATIENT COMPLETELY RECOVERED AT THIS TIME AND REMAINED NEUROLOGICALLY INTO ACT FOR THE REMAINDER OF THE PROCEDURE AND IN THE RECOVERY. NO OTHER COMPLICATION OCCURRED AND THE PATIENT LEFT THE ANGIO SUITE IN STABLE CONDITION AND COMPLETELY INTACT. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH PRECISE LOT NUMBER PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE STERILE LOT NUMBERS OF THE ANGIOGUARD DEVICE WAS NOT PROVIDED, THEREFORE, NO REVIEW OF MANUFACTURING DOCUMENTATION COULD BE PERFORMED. BRADYCARDIA IS A WELL-KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. THE HEMODYNAMIC INSTABILITY THAT OCCURS BOTH DURING AND AFTER CAROTID STENT IMPLANTATION IS INFLUENCE BY THE BARO-RECEPTORS, WHICH ARE LOCATED AT THE CAROTID BIFURCATION. THESE BARO-RECEPTORS ARE STIMULATED BY THE STRETCH OF INTERVENTIONAL BALLOONS, SDS, AND DISTAL PROTECTION DEVICES, INITIATING A REFLEX VIA THE GLOSSOPHARYNGEAL NERVE. THIS RESULTS IN A FALL IN BLOOD PRESSURE AND BRADYCARDIA. STENT PLACEMENT MAY PROMOTE PERSISTENT STIMULATION OF THESE BARO-RECEPTORS. THESE REACTIONS ARE ANTICIPATED RELATIVELY SHORT-TERM ADVERSE EVENTS. THERE IS NO EVIDENCE THAT THE EVENT WAS RELATED TO A MANUFACTURING ISSUE, THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBER 9616099-2013-00243.

    Additional Manufacturer Narrative · 1

    THE PATIENT TOLERATED THIS WITHOUT A PROBLEM AND INJECTION AFTER THE PREDILATATION SHOWED IMPROVEMENT IN THE AREA OF THE STENOSIS. SOME MILD VASOSPASM WAS SEEN AROUND THE DISTAL PROTECTION DEVICE; HOWEVER, THIS WAS NOT FLOW-LIMITING AT THIS TIME. THEN THE PRECISE STENT OF 8 X 30 MM WAS DEPLOYED IN THE AREA OF STENOSIS AND THE PATIENT TOLERATED THIS WITHOUT A PROBLEM AS WELL. SINCE SOME RESIDUAL STENOSIS REMAINED AT THE WAIST OF THE STENT A POST-DILATION WAS PERFORMED WITH A 5 MM BALLOON. AFTER THE POST-DILATION, THE PATIENT DEVELOPED BRADYCARDIA WHICH LASTED APPROXIMATELY 15 SECONDS AND WE TREATED THE BRADYCARDIA WITH .6 MG OF ATROPINE INFUSION. THE PATIENT BECAME WEAK IN THE RIGHT UPPER EXTREMITY DURING THE BRADYCARDIA EPISODE THEN BRIEFLY RECOVERED AND THEN BECAME COMPLETELY UNRESPONSIVE FOR A SHORT PERIOD. INJECTION DURING THIS TIME SHOWED COMPLETE OCCLUSION OF THE INTERNAL CAROTID ABOVE THE STENT IN THE AREA OF THE ANGIOGUARD. THIS WAS PRESUMABLY FROM SEVERE VASOSPASM AT THE LEVEL OF THE ANGIOGUARD. WE RAPIDLY ADVANCED A 5F UNKNOWN CATHETER OVER THE EXISTING WIRE AND PERFORMED SUCTION OF ANY THROMBUS THAT MAY HAVE FORMED ABOVE THE STENT THROUGH THE GUIDE CATHETER. NO CLOTS WERE SEEN IN THE ASPIRATE. THEN THE GUIDE CATHETER WAS RAPIDLY REMOVED AND THE CAPTURE CATHETER OF THE ANGIOGUARD WAS ADVANCED AND THE ANGIOGUARD WAS CAPTURED AND REMOVED. AFTER REMOVAL OF THE ANGIOGUARD, INJECTION SHOWED SEVERE SPASM IN AN OTHERWISE PATENT INTERNAL CAROTID ARTERY. THE SPASM WAS AT THE LEVEL OF THE ANGIOGUARD AND SEVERAL INCHES ABOVE THE STENT WHICH APPEARED TO BE COMPLETELY PATENT AND NONSTENOTIC. APPROXIMATELY 600MG OF NITROGLYCERIN WAS INFUSED THROUGH THE UNKNOWN CATHETER INTO THE CAROTID ARTERY AND THIS RESULTED IN COMPLETE RESOLUTION OF FLOW WITH NO RESIDUAL SPASM AND EXCELLENT RADIOGRAPHIC RESULTS. THE PATIENT COMPLETELY RECOVERED AT THIS TIME AND REMAINED NEUROLOGICALLY INTO ACT FOR THE REMAINDER OF THE PROCEDURE AND IN THE RECOVERY. NO OTHER COMPLICATION OCCURRED AND THE PATIENT LEFT THE ANGIO SUITE IN STABLE CONDITION AND COMPLETELY INTACT. CONCOMITANT MEDICATIONS: NITROGLYCERIN WAS GIVEN DURING THE PROCEDURE. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND PLAVIX. PLEASE NOTE THAT THE CATALOG AND LOT NUMBERS FOR THE ANGIOGUARD DEVICE ARE NOT AVAILABLE. THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBER 9616099-2013-00243.

    Description of Event or Problem · 1

    THE SITE INDICATED THAT DURING THE USE OF AN UNKNOWN PRECISE STENT AND UNKNOWN ANGIOGUARD EMBOLIC PROTECTIVE DEVICE THE PATIENT DEVELOPED SPASM AROUND THE ANGIOGUARD, BECAME BRADYCARDIC AND UNRESPONSIVE AND ONCE THE DEVICE WAS REMOVED, THE PATIENT WAS NORMAL. A 5F SHEATH WAS PLACED AND A 5F UNKNOWN CATHETER WAS ADVANCED INITIALLY INTO THE RIGHT COMMON CAROTID ARTERY. THERE IS SELF-LIKE PLAQUE AT THE RIGHT INTERNAL CAROTID ORIGIN WHICH CONSTITUTES AN APPROXIMATELY 60% STENOSIS. THERE IS ULCERATION WITHIN THE PLAQUE. DISTALLY, THERE IS GOOD FLOW IN THE RIGHT INTERNAL CAROTID ARTERY; HOWEVER, THE RIGHT A1 SEGMENT IS SMALL CALIBER AND THE RIGHT ACA FLOW IS MAINLY FROM THE LEFT SIDE. RIGHT MCA IS UNREMARKABLE. AFTER THESE FINDINGS WERE MADE, CATHETER WAS BROUGHT BACK A D ADVANCED INTO THE LEFT COMMON CAROTID. INJECTIONS SHOWED SEVERE STENOSIS IN THE VICINITY OF 90%. THERE IS FOCAL PLAQUE AT THE LEFT ICA ORIGIN CONSTITUTING THE STENOTIC LESION. BEYOND THIS, LEFT INTERNAL CAROTID IS PATENT WITH ANTEGRADE FLOW AND THERE IS GOOD FLOW IN THE LEFT ACA AND MCA. THERE IS CROSS FILLING OF THE RIGHT ACA THROUGH THE LEFT SIDE. AFTER THESE FINDINGS WERE MADE AND CONFIRMED ON MULTIPLE PROJECTIONS, MEASUREMENTS WERE OBTAINED AND THE INTERNAL CAROTID WAS MEASURED TO BE 5.15MM. THE COMMON CAROTID WAS MEASURED TO BE 6MM. AT THIS POINT, THE UNKNOWN CATHETER WAS MANIPULATED INTO THE EXTERNAL CAROTID OVER A GLIDEWIRE AND UNDER ROADMAP GUIDANCE. THE GUIDEWIRE WAS EXCHANGED FOR A STIFF UNKNOWN WIRE AND THE CATHETER AND THE GROIN SHEATH WERE EXCHANGED FOR A SHUTTLE 6F SHEATH THAT WAS BROUGHT OVER THE WIRE INTO THE COMMON CAROTID. A ROADMAP WAS CREATED AND THE STENOTIC ICA ORIGIN WAS NEGOTIATED WITH THE ANGIOGUARD DISTAL PROTECTION SYSTEM. THE ANGIOGUARD FILTER WAS DEPLOYED IN THE MID CERVICAL CAROTID SEVERAL INCHES ABOVE THE STENOTIC AREA. THEN A PREDILATATION OF THE STENOTIC AREA WAS PERFORMED WITH A 3.5MM BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172228 ANGIOGUARD EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE NTE CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention