BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 2768284 · Received October 2, 2012

    Report

    Report Number
    1016427-2012-00125
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    August 31, 2012
    Report Date
    September 14, 2012
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE (B)(6) REGISTRY, POST STENT PLACEMENT THE PATIENT EXPERIENCED APHASIA AND HEMIPARESIS ON THE RIGHT SIDE WHICH WAS DIAGNOSED AS A CEREBRAL VASCULAR ACCIDENT AND HYPOPERFUSION SYNDROME. THE PATIENT IS A (B)(6) FEMALE WHO WAS ENROLLED IN THE (B)(6) STUDY FOR STENTING OF THE PROXIMAL LEFT INTERNAL CAROTID ARTERY. THE VESSEL WAS DESCRIBED AS ECCENTRIC AND ULCERATED, MODERATELY CALCIFIED AND MODERATELY TORTUOUS WITH A 90% STENOSIS. A 6MM ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS PLACED DISTAL TO THE SEVERE ICA STENOSIS WHERE THE FILTER EXPANDED WITHOUT DIFFICULTY. THE PATIENT HAD ALREADY BEEN HEPARINIZED AND HER ACT WAS THERAPEUTIC. PRE-DILATION OF THE LESION WAS PREFORMED WITH AN AVIATOR BALLOON. FOLLOWING THIS SIGNIFICANT RECOIL IN THE LEFT ICA WAS NOTICED. A PRECISE STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION. THE STENT WAS POST-DILATED AS IT WAS NOTED THAT THE STENT HAD SIGNIFICANTLY RECOILED AND THERE HAD APPEARED TO BE AT LEAST A 50% RESIDUAL STENOSIS. AS SOON AS THE POST-DILATION BALLOON WAS INFLATED THE PATIENT BECAME APHASIC, BUT WAS STILL MOVING ALL FOUR EXTREMITIES. AN ANGIOGRAM WAS PERFORMED WHICH REVEALED BRISK FLOW THROUGH THE STENT AS WELL AS THE ICA TERRITORY. AN EXPORT ASPIRATION CATHETER WAS INSERTED TO MAKE SURE THERE WAS NO DEBRIS TRAPPED UNDER THE FILTER, ALTHOUGH NONE HAD BEEN SEEN ANGIOGRAPHICALLY. THE ANGIOGUARD WAS REMOVED AND THE PROCEDURE WAS COMPLETED. PRIOR TO THE PROCEDURE THE PATIENT'S BLOOD PRESSURE WAS 240/130. SHE WAS GIVEN 10MG OF HYDRALAZINE AND THE PRESSURE WAS BROUGHT DOWN TO 200/90. AFTER POST-DILATION THE PATIENT'S PRESSURE DROPPED TO A SYSTOLIC OF 90. IT WAS FELT THAT THE RAPID HYPOTENSION WAS THE CAUSE OF THE PATIENT'S TRANSIENT NEUROLOGICAL DEFICIT. HER BLOOD PRESSURE WAS IMMEDIATELY REVERSED WITH NEO-SYNEPHRINE AND DOPAMINE. STROKE ALERT WAS CALLED AND THE NEUROLOGIST, AFTER ASSESSING THE PATIENT AGREED THAT THIS NEUROLOGICAL DEFICIT WAS MOST LIKELY DUE TO HYPOPERFUSION SYNDROME. THE PATIENT'S SYMPTOMS COMPLETELY RESOLVED WITHIN 48 HOURS WITH BLOOD PRESSURE MAINTENANCE. THE PATIENT'S MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA, ABNORMAL STRESS TEST, CONGESTIVE HEART FAILURE, CORONARY ARTERY DISEASE, CORONARY PERCUTANEOUS REVASCULARIZATION AND HYPERTENSION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. HYPOTENSION, HYPOPERFUSION AND THE RESULTANT TIA AND TIA SYMPTOMS ARE WELL-KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. TIA SYMPTOMS ARE SIMILAR TO THOSE OF STROKE BUT DO NOT LAST AS LONG. TYPICALLY SYMPTOMS OF A TIA OFTEN LAST ONLY A FEW MINUTES, MOST SYMPTOMS RESOLVE WITHIN AN HOUR BUT THEY MAY LAST UP TO 24 HOURS. TIA OCCURS WHEN THE BLOOD SUPPLY TO PART OF THE BRAIN IS BRIEFLY INTERRUPTED. THE HEMODYNAMIC INSTABILITY THAT OCCURS BOTH DURING AND AFTER CAROTID STENT IMPLANTATION IS INFLUENCED BY THE BARO-RECEPTORS, WHICH ARE LOCATED AT THE CAROTID BIFURCATION. THESE BARO-RECEPTORS ARE STIMULATED BY THE STRETCH OF INTERVENTIONAL BALLOONS, SDS (STENT DELIVERY SYSTEM) 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 ASSOCIATED WITH THE COMPRESSION OF THE BARO-RECEPTORS DURING BALLOON INFLATION, STENT IMPLANTATION AND FILTER DEVICE MANIPULATION. CERTAIN FACTORS MAY INFLUENCE THE LIKELIHOOD OF ANTICIPATED BARO-RECEPTOR REACTIONS SUCH AS ADVANCED AGE, VENTRICULAR DYSFUNCTION AND GENDER. APHASIA IS A WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. 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. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF FOUR PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2012-00539, 9616099-2012-00540, 1016427-2012-00125, AND 9616099-2012-00541.

    Additional Manufacturer Narrative · 1

    HER BLOOD PRESSURE WAS IMMEDIATELY REVERSED WITH NEO-SYNEPHRINE AND DOPAMINE. STROKE ALERT WAS CALLED AND THE NEUROLOGIST, AFTER ASSESSING THE PATIENT AGREED THAT THIS NEUROLOGICAL DEFICIT WAS MOST LIKELY DUE TO HYPOPERFUSION SYNDROME. THE PHYSICIAN BELIEVED THAT HER SYMPTOMS SHOULD RESOLVE WITHIN 48 HOURS WITH BLOOD PRESSURE MAINTENANCE. THE PATIENT WAS AWAKE AT THE END OF THE PROCEDURE. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF FOUR PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2012-00539, 9616099-2012-00540, 1016427-2012-00125, AND 9616099-2012-00541.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) REGISTRY DURING CATHETERIZATION THE PATIENT EXPERIENCED APHASIA, HEMIPARESIS IN THE RIGHT SIDE. THE PATIENT WAS DIAGNOSED WITH A CEREBRAL VASCULAR ACCIDENT STATUS POST STENT PLACEMENT AND HYPOPERFUSION SYNDROME. THE PATIENT IS A (B)(6) FEMALE WHO WAS ENROLLED IN THE (B)(4) STUDY FOR STENTING OF THE CAROTID ARTERY. THE TARGET LESION LOCATION WAS TH E PROXIMAL LEFT INTERNAL CAROTID ARTERY (L5). THE VESSEL WAS DESCRIBED AS ECCENTRIC AND ULCERATED, MODERATELY CALCIFIED AND MODERATELY TORTUOUS. THE RATE OF STENOSIS WAS 90%. A 6MM ANGIOGUARD ((B)(4)/ LOT 70911439) EMBOLIC PROTECTION DEVICE WAS PLACED DISTAL TO THE SEVERE ICA STENOSIS. THE FILTER EXPANDED WITHOUT DIFFICULTY. THE PATIENT HAD ALREADY BEEN HEPARINIZED AND HER ACT WAS THERAPEUTIC. PRE-DILATION OF THE LESION WAS PREFORMED WITH AN AVIATOR 5.5X30MM BALLOON TO 10 ATM. FOLLOWING THIS SIGNIFICANT RECOIL IN THE LEFT ICA WAS NOTICED. A PRECISE ((B)(4)/ LOT 15575459) STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION. THE STENT WAS POST-DILATED WITH A 6X30 AVIATOR PLUS BALLOON AT 12 ATMOSPHERES. IT WAS NOTED THAT THE STENT WAS POST DILATED SINCE IT HAD SIGNIFICANTLY RECOILED AND THERE HAD APPEARED TO BE AT LEAST A 50% RESIDUAL STENOSIS. AS SOON AS THE POST-DILATION BALLOON WAS INFLATED THE PATIENT BECAME APHASIC, BUT WAS STILL MOVING ALL FOUR EXTREMITIES. AN ANGIOGRAM WAS PERFORMED WHICH REVEALED BRISK FLOW THROUGH THE STENT AS WELL AS THE ICA TERRITORY. AN EXPORT ASPIRATION CATHETER WAS INSERTED TO MAKE SURE THERE WAS NO DEBRIS TRAPPED UNDER THE FILTER, ALTHOUGH NONE HAD BEEN SEEN ANGIOGRAPHICALLY. THE ANGIOGUARD WAS REMOVED. THE PROCEDURE WAS COMPLETED. PRIOR TO THE PROCEDURE THE PATIENT'S BLOOD PRESSURE WAS 240/130. SHE WAS GIVEN 10MG OF HYDRALAZINE AND THE PRESSURE WAS BROUGHT DOWN TO 200/90. AFTER POST-DILATION THE PATIENT'S PRESSURE DROPPED TO A SYSTOLIC OF 90. IT WAS FELT THAT THE RAPID HYPOTENSION WAS THE CAUSE OF THE PATIENT'S TRANSIENT NEUROLOGICAL DEFICIT.

    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 70911439

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R PRECISE, AVIATOR