BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 2073565 · Received May 2, 2011

    Report

    Report Number
    1016427-2011-00035
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    February 26, 2010
    Report Date
    April 7, 2011
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2011-00035, 9616099-2011-00291 AND 9616099-2011-00292.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED VIA THE (B)(4) REGISTRY, A PATIENT EXPERIENCED HYPOTENSION AND BRADYCARDIA DURING THE PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 99% STENOSIS IN THE LEFT OSTIAL INTERNAL CAROTID ARTERY. THE LESION WAS 15MM IN LENGTH. THE REFERENCE VESSEL WAS 6.0MM IN DIAMETER AND MILDLY TORTUOUS. A 6MM ANGIOGUARD RX WAS DEPLOYED BEYOND THE TARGET LESION, AND AN 8.0 X 40MM PRECISE PRO RX WAS THEN IMPLANTED. THE STENT WAS POST-DILATED WITH A 3.0 X 20MM FIRESTAR BALLOON DURING WHICH TIME THE PATIENT'S BLOOD PRESSURE DROPPED TO 87/40 (PRE-PROCEDURE WAS 167/76) AND THE PULSE DROPPED TO 53 (PRE-PROCEDURE WAS 61). BLOOD PRESSURE AND PULSE NORMALIZED AFTER TREATMENT WITH NEOSYNEPHRINE AND A DOPAMINE DRIP. THE PATIENT'S RESIDUAL STENOSIS WAS 10%. SHE WAS TRANSFERRED TO INTENSIVE CARE POST-PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL APPROXIMATELY 2 DAYS AFTER THE PROCEDURE. IT WAS REPORTED THAT THERE WERE NO POST-PROCEDURE NEUROLOGICAL EVENTS. THE PATIENT'S MEDICAL HISTORY INCLUDES STROKE, CORONARY ARTERY DISEASE AND MYOCARDIAL INFARCTION. LAKE REGION LOT NUMBER 07403409 IS CORDIS LOT NUMBER 71208501. PER LAKE REGION REPORT C 10,335 LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 07403409. THIS PACKAGING LOT CONTAINED 133 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON (B)(6) 2009. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. 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. HEMODYNAMIC DEPRESSION DURING CAROTID ARTERY STENTING PROCEDURES IS A COMMON EVENT AND IS MOST LIKELY RELATED TO CORONARY SINUS REFLEX OR VAGAL RESPONSE. THE VAGUS NERVE ENTERS THE THORAX BETWEEN COMMON CAROTID ARTERY AND SUBCLAVIAN ARTERY AND DESCENDS DOWNWARD. DURING BALLOON INFLATION OR STENT DEPLOYMENT, PRESSURE CAN BE EXERTED ON THE NERVE STIMULATING A PARASYMPATHETIC RESPONSE, I.E. BRADYCARDIA, HYPOTENSION, HEART BLOCK, ASYSTOLE, ETC. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT IS RELATED TO A MANUFACTURING ISSUE OR DEFECT OF THE DEVICE, BUT IS LIKELY RELATED TO VESSEL CHARACTERISTICS, PATIENT AND PROCEDURAL FACTORS. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2011-00035, 9616099-2011-00291 AND 9616099-2011-00292.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(4) REGISTRY, A PATIENT EXPERIENCED HYPOTENSION AND BRADYCARDIA DURING THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 99% STENOSIS IN THE LEFT OSTIAL INTERNAL CAROTID ARTERY. THE LESION WAS 15MM IN LENGTH. THE REFERENCE VESSEL WAS 6.0MM IN DIAMETER AND MILDLY TORTUOUS. A 6MM ANGIOGUARD RX WAS DEPLOYED BEYOND THE TARGET LESION, AND AN 8.0 X 40MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION. THE STENT WAS POST-DILATED WITH A 3.0 X 20MM FIRESTAR BALLOON AND THE PATIENT'S BLOOD PRESSURE DROPPED TO 87/40 (PRE-PROCEDURE WAS 167/76) AND PULSE DROPPED TO 53 (PRE-PROCEDURE WAS 61). HER BLOOD PRESSURE AND PULSE NORMALIZED AFTER TREATMENT WITH NEOSYNEPHRINE AND A DOPAMINE DRIP. THE PATIENT'S RESIDUAL STENOSIS WAS 10%. SHE WAS TRANSFERRED TO INTENSIVE CARE POST-PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL APPROXIMATELY 2 DAYS AFTER THE PROCEDURE. PRE-PROCEDURE (B)(6) STROKE SCALE SCORE WAS 9 (PATIENT HAD A HISTORY OF STROKE) AND POST-PROCEDURE WAS 17. THE PRE AND POST STROKE SCORES WERE PERFORMED BY DIFFERENT REVIEWERS AND IT WAS REPORTED THAT THERE WERE NO POST-PROCEDURE NEUROLOGICAL EVENTS.

    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 71208501

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention HEPARIN, ASPIRIN, CLOPIDOGREL