BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1981782 · Received February 8, 2011

    Report

    Report Number
    1016427-2011-00014
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    May 27, 2010
    Report Date
    January 14, 2011
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS SYMPTOMATIC FOR THE INDEX PROCEDURE. THE TARGET LESION WAS THE OSTIUM OF THE LICA. THE TARGET LESION WAS REPORTED TO BE: A 95% STENOSIS, 20 MM LENGTH, 6.0 MM REFERENCE DIAMETER, AND CONCENTRIC. THE LESION WAS PRE-DILATED. AN ANGIOGUARD 6 MM EMBOLIC PROTECTION DEVICE WAS USED FOR THE PROCEDURE. A PRECISE 8 X 30 STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE RESIDUAL STENOSIS WAS 0%. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #1016427-2011-00014 AND #9616099-2011-00086.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING THE INDEX PROCEDURE THIS (B)(4) STUDY PATIENT SUFFERED AN ISCHEMIC STROKE WHILE THE ANGIOGUARD HAD WITHDRAWAL DIFFICULTY SECONDARY TO FRACTURE AND SEPARATION. THE PATIENT WAS SYMPTOMATIC FOR THE INDEX PROCEDURE. THE TARGET LESION WAS THE OSTIUM OF THE LICA. THE TARGET LESION WAS REPORTED TO BE: A 95% STENOSIS, 20 MM LENGTH, 6.0 MM REFERENCE DIAMETER, AND CONCENTRIC. THE LESION WAS PRE-DILATED. AN ANGIOGUARD 6 MM EMBOLIC PROTECTION DEVICE WAS USED FOR THE PROCEDURE. A PRECISE 8 X 30 STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE RESIDUAL STENOSIS WAS 0%. THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND HAD A PRECISE 8 X 30 STENT SUCCESSFULLY IMPLANTED IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY (LICA) DURING THE STUDY INDEX PROCEDURE. AFTER SUCCESSFULLY DEPLOYING THE STENT, THE PHYSICIAN HAD DIFFICULTY WITHDRAWING THE 6 MM ANGIOGUARD EMBOLIC PROTECTION DEVICE AFTER CAPTURING THE BASKET AND THE DEVICE FRACTURED/SEPARATED. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED AN ISCHEMIC STROKE AS A RESULT THAT WAS CHARACTERIZED BY BEHAVIORAL CHANGE, DYSARTHRIA AND RIGHT HEMIPARESIS. THE ONSET OF SYMPTOMS WAS REPORTED TO BE STEP-LIKE. THE PATIENT WAS REPORTED TO HAVE MADE A FULL RECOVERY FROM THE ISCHEMIC STROKE. EMERGENT CAROTID SURGERY WAS PERFORMED TO SUCCESSFULLY REMOVE THE FRACTURED DEVICE. THE DEVICE WAS SUCCESSFULLY REMOVED WITH NO DEBRIS NOTED. THE PATIENT WAS DISCHARGED SEVEN DAYS AFTER THE PROCEDURE. THE ANGIOGUARD WAS NOT RETURNED, AND THE STENT REMAINS IMPLANTED THUS NEITHER DEVICE WAS AVAILABLE FOR ANALYSIS. (B)(4): NOTE: LAKE REGION LOT NUMBER 01417754 WHICH IS CORDIS LOT NUMBER 70110507. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01417754. THIS PACKAGING LOT CONTAINED 107 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON FEBRUARY 15, 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE COMPLAINT OF DEVICE SEPARATION COULD NOT BE CONFIRMED WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ISCHEMIC STROKE IS A WELL-KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. STROKE IS ASSOCIATED WITH A STOPPAGE OR SLOWING OF BLOOD FLOW TO THE CEREBRAL ARTERIES. 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. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS, PARTICULARLY THE ANGIOGUARD SEPARATION AND RETRIEVAL MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #1016427-2011-00014 AND #9616099-2011-00086.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND HAD A PRECISE 8 X 30 STENT SUCCESSFULLY IMPLANTED IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY (LICA) DURING THE STUDY INDEX PROCEDURE. AFTER SUCCESSFULLY DEPLOYING THE STENT, THE PHYSICIAN HAD DIFFICULTY WITHDRAWING THE 6 MM ANGIOGUARD EMBOLIC PROTECTION DEVICE AFTER CAPTURING THE BASKET AND THE DEVICE FRACTURED/SEPARATED. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED AN ISCHEMIC STROKE AS A RESULT THAT WAS CHARACTERIZED BY BEHAVIORAL CHANGE, DYSARTHRIA AND RIGHT HEMIPARESIS. THE ONSET OF SYMPTOMS WAS REPORTED TO BE STEP-LIKE. THE PATIENT WAS REPORTED TO HAVE MADE A FULL RECOVERY FROM THE ISCHEMIC STROKE. EMERGENT CAROTID SURGERY WAS PERFORMED TO SUCCESSFULLY REMOVE THE FRACTURED DEVICE. THE DEVICE WAS SUCCESSFULLY REMOVED WITH NO DEBRIS NOTED. THE PATIENT WAS DISCHARGED SEVEN DAYS AFTER THE 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 NA 70110507

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R PRECISE 8 X 30 STENT