BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 3918221 · Received July 8, 2014

    Report

    Report Number
    1016427-2014-00076
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 1, 2010
    Report Date
    June 17, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOST COMMON EPD DEPLOYED WAS THE ANGIOGUARD EMBOLI CAPTURE GUIDEWIRE SYSTEM (25.4% OF CASES). PRE-DILATATION WITH A 2.0 TO 2.5MM CORONARY ANGIOPLASTY BALLOON WAS PERFORMED ONLY IN CASES WHERE IT WAS NOT POSSIBLE TO PASS THE LESION WITH A DISTAL PROTECTION DEVICE OR IT WAS NOT POSSIBLE TO PASS THE LESION WITH THE STENT AFTER PLACEMENT OF AN EPD. POSTDILATION WAS ROUTINELY PERFORMED AFTER STENT IMPLANTATION AND BEFORE EPD REMOVAL USING A SEMI-COMPLIANT BALLOON, WITH SIZING BASED ON THE DIAMETER OF THE ICA DISTAL TO THE LESION (MAX DIAMETER OF 6MM). STENTS USED IN THE STUDY INCLUDED RX ACCULINK, CAROTID WALLSTENT, AND ¿OTHERS.¿ ALL PATIENTS WERE PRE-TREATED WITH ASPIRIN (100 MG/D); A THIENOPYRIDINE (TICLOPIDINE 250MG TWICE DAILY OR CLOPIDOGREL 75MG/D) WAS STARTED AT LEAST 5 DAYS BEFORE THE PROCEDURE. ALL PATIENTS WERE DISCHARGED ON DUAL ANTIPLATELET THERAPY WITH ASPIRIN (INDEFINITELY) PLUS TICLOPIDINE OR CLOPIDOGREL FOR ONE MONTH. PRE-DILATION OF THE STENOTIC LESION WAS PERFORMED IN 101 CASES. AN EPD WAS SUCCESSFULLY DEPLOYED IN 512 PROCEDURES; IN THE OTHER 24 CASES (ALL TREATED IN THE FIRST 3 YEARS OF EXPERIENCE), IT WAS IMPOSSIBLE TO CROSS THE LESION WITH AN EPD DUE TO TIGHT STENOSIS OR EXTREME TORTUOSITY OF THE CAROTID ARTERY. FINAL ANGIOGRAPHIC SUCCESS WAS ACHIEVED IN 99.1% OF CASES.). FURTHER INFORMATION IS NOT AVAILABLE. THE EXACT DATE OF PUBLICATION IS UNKNOWN; THEREFORE, THE EVENT DATE IS BEING SUBMITTED AS (B)(6) 2010. THE GENDER OF THE PATIENT IS UNKNOWN. THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW OF THIS DEVICE. THE CITATION IS AS FOLLOWS: IELASI, A ET AL (2010, JUNE). CLINICAL OUTCOMES FOLLOWING PROTECTED CAROTID ARTERY STENTING IN SYMPTOMATIC AND ASYMPTOMATIC PATIENTS. J ENDOVASCULAR THERAPY, 17, 298-307. THIS IS THE INITIAL AND FINAL REPORT FOR THIS DEVICE. CONCOMITANT MEDICATIONS: PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, TICLOPIDINE, CLOPIDOGREL. COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY IELASI ET AL CLINICAL OUTCOMES FOLLOWING PROTECTED CAROTID ARTERY STENTING IN SYMPTOMATIC AND ASYMPTOMATIC PATIENTS, J ENDOVASC THERAPY 17 (2010) 298-307; IN ONE CASE, AN ANGIOGUARD EPD INDUCED A DISSECTION OF THE LEFT INTERNAL CAROTID ARTERY (ICA) THAT REQUIRED THE IMPLANTATION OF 3 STENTS. THE CASE WAS RESOLVED WITHOUT NEUROLOGICAL SEQUELAE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN GOOD HEALTH. THE PURPOSE OF THE STUDY WAS TO EVALUATE PERIPROCEDURAL AND 1-YEAR CLINICAL OUTCOMES FOLLOWING CAROTID ARTERY STENTING (CAS) WITH ROUTINE USE OF A CEREBRAL EMBOLIC PROTECTION DEVICE (EPD). A RETROSPECTIVE COHORT ANALYSIS WAS CONDUCTED OF 490 CONSECUTIVE PATIENTS WHO UNDERWENT CAS AT 2 INSTITUTIONS WITH LARGE REFERRAL PRACTICES. NEARLY A QUARTER OF THE COHORT HAD DIABETES; 91 PATIENTS HAD BILATERAL CAROTID DISEASE AT PRESENTATION. NEARLY HALF ((B)(4)) OF THE STENOTIC VESSELS WERE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA), WHILE BULB LESIONS INVOLVING THE PROXIMAL AND MID ICA WERE THE MOST COMMON ((B)(4)). SYMPTOMATIC PATIENTS WITH A >50% CAROTID ARTERY STENOSIS OR ASYMPTOMATIC PATIENTS WITH A GREATER THAN OR EQUAL TO 70% CAROTID ARTERY STENOSIS ON COLOR DOPPLER ULTRASONOGRAPHY UNDERWENT CAROTID ANGIOGRAPHY. OF THESE, ALL SYMPTOMATIC PATIENTS WITH ANGIOGRAPHIC EVIDENCE OF GREATER THAN OR EQUAL TO 50% STENOSIS AND ASYMPTOMATIC PATIENTS WITH A GREATER THAN OR EQUAL TO 80% DIAMETER STENOSIS WERE ELIGIBLE FOR CAS. PATIENTS WITH DOCUMENTED ISCHEMIC CEREBRAL EVENTS (STROKE OR TIA) OCCURRING IN THE 6 MONTHS PRIOR TO THE PROCEDURE WERE CONSIDERED SYMPTOMATIC (N=166); THE 327 REMAINING PATIENTS WERE CONSIDERED ASYMPTOMATIC. ALL SYMPTOMATIC PATIENTS UNDERWENT PREPROCEDURAL NEUROLOGICAL EXAMINATION. ALSO, ALL PATIENTS WITH ANY POSTPROCEDURAL NEUROLOGICAL SYMPTOM OR DEFICIT UNDERWENT THOROUGH EVALUATION BY A BOARD-CERTIFIED NEUROLOGIST. PLACEMENT OF A CEREBRAL PROTECTION DEVICE WAS ATTEMPTED IN ALL PROCEDURES. THE MOST COMMON EPD DEPLOYED WAS THE ANGIOGUARD EMBOLI CAPTURE GUIDEWIRE SYSTEM (25.4% OF CASES). PRE-DILATATION WITH A 2.0 TO 2.5MM CORONARY ANGIOPLASTY BALLOON WAS PERFORMED ONLY IN CASES WHERE IT WAS NOT POSSIBLE TO PASS THE LESION WITH A DISTAL PROTECTION DEVICE OR IT WAS NOT POSSIBLE TO PASS THE LESION WITH THE STENT AFTER PLACEMENT OF AN EPD. POSTDILATION WAS ROUTINELY PERFORMED AFTER STENT IMPLANTATION AND BEFORE EPD REMOVAL USING A SEMI-COMPLIANT BALLOON, WITH SIZING BASED ON THE DIAMETER OF THE ICA DISTAL TO THE LESION (MAX DIAMETER OF 6MM). STENTS USED IN THE STUDY INCLUDED RX ACCULINK, CAROTID WALLSTENT, AND ¿OTHERS.¿ ALL PATIENTS WERE PRE-TREATED WITH ASPIRIN (100 MG/D); A THIENOPYRIDINE (TICLOPIDINE 250MG TWICE DAILY OR CLOPIDOGREL 75MG/D) WAS STARTED AT LEAST 5 DAYS BEFORE THE PROCEDURE. ALL PATIENTS WERE DISCHARGED ON DUAL ANTIPLATELET THERAPY WITH ASPIRIN (INDEFINITELY) PLUS TICLOPIDINE OR CLOPIDOGREL FOR ONE MONTH. PRE-DILATION OF THE STENOTIC LESION WAS PERFORMED IN 101 CASES. AN EPD WAS SUCCESSFULLY DEPLOYED IN 512 PROCEDURES; IN THE OTHER 24 CASES (ALL TREATED IN THE FIRST 3 YEARS OF EXPERIENCE), IT WAS IMPOSSIBLE TO CROSS THE LESION WITH AN EPD DUE TO TIGHT STENOSIS OR EXTREME TORTUOSITY OF THE CAROTID ARTERY. FINAL ANGIOGRAPHIC SUCCESS WAS ACHIEVED IN 99.1% OF CASES.). FURTHER INFORMATION IS NOT AVAILABLE. THE COMPLAINT PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. VESSELS THAT ARE RESISTANT TO ANGIOPLASTY HAVE A HIGHER RISK OF INTIMAL DISSECTION DURING INTERVENTIONAL PROCEDURES. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. IN VIEW OF THE PLANNED STENT PROCEDURE, THE DISSECTION WAS APPROPRIATELY TREATED WITH STENT IMPLANTATION. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. THIS DOES NOT REPRESENT DEVICE MALFUNCTION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT VESSEL / LESION CHARACTERISTICS AND POSSIBLY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY IELASI ET AL CLINICAL OUTCOMES FOLLOWING PROTECTED CAROTID ARTERY STENTING IN SYMPTOMATIC AND ASYMPTOMATIC PATIENTS, J ENDOVASC THERAPY 17 (2010) 298-307. IN ONE CASE, AN ANGIOGUARD EPD INDUCED A DISSECTION OF THE LEFT INTERNAL CAROTID ARTERY (ICA) THAT REQUIRED THE IMPLANTATION OF 3 STENTS. THE CASE WAS RESOLVED WITHOUT NEUROLOGICAL SEQUELAE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN GOOD HEALTH. THE PURPOSE OF THE STUDY WAS TO EVALUATE PERIPROCEDURAL AND 1-YEAR CLINICAL OUTCOMES FOLLOWING CAROTID ARTERY STENTING (CAS) WITH ROUTINE USE OF A CEREBRAL EMBOLIC PROTECTION DEVICE (EPD). A RETROSPECTIVE COHORT ANALYSIS WAS CONDUCTED OF 490 CONSECUTIVE PATIENTS WHO UNDERWENT CAS AT 2 INSTITUTIONS WITH LARGE REFERRAL PRACTICES. NEARLY A QUARTER OF THE COHORT HAD DIABETES; 91 PATIENTS HAD BILATERAL CAROTID DISEASE AT PRESENTATION. NEARLY HALF ((B)(4)) OF THE STENOTIC VESSELS WERE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA), WHILE BULB LESIONS INVOLVING THE PROXIMAL AND MID ICA WERE THE MOST COMMON ((B)(4)). SYMPTOMATIC PATIENTS WITH A >50% CAROTID ARTERY STENOSIS OR ASYMPTOMATIC PATIENTS WITH A GREATER THAN OR EQUAL TO 70% CAROTID ARTERY STENOSIS ON COLOR DOPPLER ULTRASONOGRAPHY UNDERWENT CAROTID ANGIOGRAPHY. OF THESE, ALL SYMPTOMATIC PATIENTS WITH ANGIOGRAPHIC EVIDENCE OF GREATER THAN OR EQUAL TO 50% STENOSIS AND ASYMPTOMATIC PATIENTS WITH A GREATER THAN OR EQUAL TO 80% DIAMETER STENOSIS WERE ELIGIBLE FOR CAS. PATIENTS WITH DOCUMENTED ISCHEMIC CEREBRAL EVENTS (STROKE OR TIA) OCCURRING IN THE 6 MONTHS PRIOR TO THE PROCEDURE WERE CONSIDERED SYMPTOMATIC (N=166); THE 327 REMAINING PATIENTS WERE CONSIDERED ASYMPTOMATIC. ALL SYMPTOMATIC PATIENTS UNDERWENT PREPROCEDURAL NEUROLOGICAL EXAMINATION. ALSO, ALL PATIENTS WITH ANY POSTPROCEDURAL NEUROLOGICAL SYMPTOM OR DEFICIT UNDERWENT THOROUGH EVALUATION BY A BOARD-CERTIFIED NEUROLOGIST. PLACEMENT OF A CEREBRAL PROTECTION DEVICE WAS ATTEMPTED IN ALL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396406 ANGIOGUARD EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE NTE CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R| S