BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENVOY 6F

    MDR report key: 6607533 · Received June 2, 2017

    Report

    Report Number
    3008264254-2017-00063
    Event Type
    Injury
    Date Received
    June 2, 2017
    Date of Event
    March 7, 2012
    Report Date
    May 10, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    DQY
    PMA / PMN Number
    K093184
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN PART NUMBER, ALL 3 ATTEMPTS TO OBTAIN THE PRODUCT AND LOT NUMBER WERE UNSUCCESSFUL, UDI UNAVAILABLE. THE EXACT DATE OF THE PROCEDURE AS WELL AND THE PRODUCT AND LOT NUMBER COULD NOT BE OBTAINED. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. LITERATURE ARTICLE ATTACHED TO FILE: TAN, M.L., MITCHELL, P., DOWLING, R., ET AL. (2012) ¿SHORTER TIME TO INTERVENTION IMPROVES RECANALIZATION SUCCESS AND CLINICAL OUTCOME POST INTRA-ARTERIAL INTERVENTION FOR BASILAR ARTERY THROMBOSIS¿. JOURNAL OF CLINICAL NEUROSCIENCE 19 (2012) 1397¿1400. THIS IS AN INITIAL/FINAL MDR REPORT.

    Additional Manufacturer Narrative · 1

    CORRECTION AND ADDITIONAL INFORMATION: THE COMPLAINT CONCLUSION WAS INADVERTENTLY OMITTED FROM THE INITIAL MDR REPORT. CONCLUSION: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. IN ADDITION, THE LOT NUMBER WAS UNKNOWN; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. ARTERIAL DISSECTION IS A KNOWN POSSIBLE ADVERSE EVENT THAT MAY COMPLICATE AN INTRAVASCULAR PROCEDURE, AND IS LISTED IN THE INSTRUCTIONS FOR USE AS A POSSIBLE COMPLICATION. CLINICAL AND PROCEDURAL FACTORS INCLUDING VESSEL CHARACTERISTICS, TORTUOSITY, DEVICE SELECTION, AND MANIPULATION OF DEVICES WITHIN THE ARTERY ARE ALL FACTORS THAT MAY CONTRIBUTED TO THE REPORTED EVENT. WITH REVIEW OF THE REPORTED INFORMATION, THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE ARTICLE ¿SHORTER TIME TO INTERVENTION IMPROVES RECANALIZATION SUCCESS AND CLINICAL OUTCOME POST INTRA-ARTERIAL INTERVENTION FOR BASILAR ARTERY THROMBOSIS¿ BY MEI LYN TAN, PETER MITCHELL, RICHARD DOWLING, MARK TACEY, BERNARD YAN, PUBLISHED JOURNAL OF CLINICAL NEUROSCIENCE 19 (2012) 1397¿1400, IT WAS REPORTED THAT AN ARTERIAL DISSECTION WAS CAUSED BY THE PLACEMENT OF AN 6F ENVOY GUIDING CATHETER INTO THE PARENT ARTERY. NO FURTHER DEVICE, PATIENT OR PROCEDURAL INFORMATION WAS PROVIDED IN THE ARTICLE REGARDING THE DISSECTION. THE STUDY INVESTIGATED IF THE TIME OF INTERVENTION OF AN ARTERIAL CLOT PREDICTS RECANALIZATION SUCCESS LEADING TO IMPROVED CLINICAL OUTCOMES. FORTY-NINE CONSECUTIVE PATIENTS WITH BASILAR ARTERY THROMBOSIS TREATED WITH INTRA-ARTERIAL (IA) THERAPY BETWEEN 1993 AND 2011 WERE INCLUDED. PATIENT DEMOGRAPHICS, CLINICAL FEATURES, CLOT LOCATION, TIME TO INTERVENTION AND POST-PROCEDURAL THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) SCORES WERE COLLECTED. RECANALIZATION SUCCESS WAS DEFINED AS A SCORE OF TIMI 2¿3. CLINICAL OUTCOME WAS MEASURED USING THE 90-DAY MODIFIED RANKIN SCALE (MRS) SCORE, WITH GOOD NEUROLOGICAL OUTCOME DEFINED AS MRS 0¿2. THE MEAN PATIENT AGE WAS 59.8 YEARS ± 17.9 AND 36.7% WERE FEMALES. IA THERAPY WAS COMMENCED WITHIN 6 HOURS OF STROKE ONSET IN 17/49 (34.7%) PATIENTS. OF THIS 6-HOUR ONSET GROUP, 17/17 (100%) DEMONSTRATED RECANALIZATION SUCCESS (TIMI 2¿3) AND 10/17 (58.8%) ACHIEVED GOOD NEUROLOGICAL OUTCOME AT 90-DAYS. IA THERAPY WAS COMMENCED AFTER 6 HOURS OF STROKE ONSET IN 32/49 (65.3%) PATIENTS, WITH 24/32 (75%) AND 6/32 (18.75%) PATIENTS ACHIEVING RECANALIZATION SUCCESS AND GOOD OUTCOME, RESPECTIVELY. NO ADDITIONAL INFORMATION COULD BE OBTAINED FROM THE AUTHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390348 UNKNOWN ENVOY 6F PERCUTANEOUS CATHETER DQY CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention