BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE RX CAROTID STENT SYSTEM

    MDR report key: 7402014 · Received April 6, 2018

    Report

    Report Number
    2183870-2018-00208
    Event Type
    Injury
    Date Received
    April 6, 2018
    Date of Event
    August 1, 2011
    Report Date
    April 6, 2018
    Manufacturer
    MEDTRONIC COVIDIEN
    Product Code
    NIM
    PMA / PMN Number
    P060001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: AVERAGE AGE. SEX: MAJORITY GENDER. EVENT DATE IS LITERATURE ARTICLE PUBLISHED DATE ¿ ONLY MONTH AND YEAR VALID OVERLAPPED STENTING IS ASSOCIATED WITH POSTOPERATIVE HYPOTENSION AFTER CAROTID ARTERY STENTING JOURNAL OF STROKE AND CEREBROVASCULAR DISEASES (2018) VOL. 27 NO. 3 P 653-659 DOI: 10.1016/J.JSTROKECEREBROVASDIS.2017.09.041. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BETWEEN AUGUST 2011 AND APRIL 2015, 95 CONSECUTIVE PATIENTS WITH STENOSIS OF THE INTERNAL CAROTID ARTERY(ICA) UNDERWENT 106 CAROTID ARTERY STENTING(CAS) PROCEDURES WITHOUT PATIENT SELECTION. ALL PATIENTS RECEIVED MULTIPLE ANTIPLATELET DRUGS (CLOPIDOGREL AT 75 MG, ASPIRIN AT 100 MG, AND CILOSTAZOL AT 200 MG DAILY) FOR AT LEAST 1 WEEK BEFORE CAS. THE PATIENTS WERE CATEGORIZED BY THE PRESENCE OR THE ABSENCE OF POSTOPERATIVE HYPOTENSION(HT). DEMOGRAPHIC DATA, RISK FACTORS, CONDITIONS OF CAROTID ARTERY STENOSIS, PROCEDURES, AND PRE- AND INTRAOPERATIVE HEMODYNAMICS WERE COMPARED BETWEEN THESE 2 GROUPS. DURING THE PROCEDURE, FOR 10 CASES, A GUARDWIRE WAS INTRODUCED INTO THE EXTERNAL CAROTID ARTERY. UNDER DUAL PROTECTION, PRE-DILATATION WAS PERFORMED AND SELF-EXPANDING STENTS WERE DEPLOYED. MEDTRONIC PROTEGE RX STENTS WERE AMONG THOSE USED FOR THESE PROCEDURES. AN EXPORT ASPIRATION CATHETER WAS PLACED BETWEEN THE PROXIMAL END OF THE STENT AND THE DISTAL FILTER AND BLOOD ASPIRATED SEVERAL TIMES FROM THE ICA. SUBSEQUENTLY, IVUS WAS PERFORMED TO CONFIRM THE EXISTENCE OF PLAQUE PROTRUSION OR MIGRATION, AND IF MORE THAN 1 MM OF VISIBLE TISSUE WAS DETECTED ON THE LUMINAL SIDE OF THE STENT STRUTS, AN ADDITIONAL STENT WAS OVERLAPPED TO COVER AND COMPRESS ALL OF THE PLAQUE COMPLETELY. TRANSIENT ISCHEMIC ATTACK(TIA) OCCURRED IN 3 CASES OVERALL. MINOR STROKE WAS OBSERVED IN 3 CASES OF PATIENTS WHO WERE IN THE POSTOPERATIVE HT GROUP AND THESE WERE SEEN TO BE RESOLVED COMPLETELY WITH 30 DAYS. PLAQUE PROTRUSION WAS DETECTED BY IVUS IN 10 CASES DURING CAS. ALL WERE COMPRESSED COMPLETELY BY OVERLAPPING AN ADDITIONAL STENT, WHICH WAS ALSO CONFIRMED BY REPETITIVE IVUS. THE OVERLAPPED STENTING WAS PERFORMED WITH 2 NON-MEDTRONIC STENTS IN 7 CASES, A MEDTRONIC PROTÉGÉ AND A NON-MEDTRONIC STENT IN 1 CASE, 2 MEDTRONIC PROTÉGÉ STENTS IN 1 CASE, AND A MEDTRONIC PROTÉGÉ AND A NON-MEDTRONIC STENT IN 1 CASE, RESPECTIVELY. BRADYCARDIA WAS OBSERVED, NONE CONTINUED AFTER THE PROCEDURE. AE RESOLVED SPONTANEOUSLY WITH THE NEED FOR INTERVENTION. IN TOTAL, INTRA- AND POSTOPERATIVE HTS WERE OBSERVED IN 43 (40.6%) AND 30 (28.3%) CASES, RESPECTIVELY. INTRAOPERATIVE HT OCCURRED IN 3 CASES AT PREDILATATION AND IN 40 AT POST DILATATION. AMONG THE CASES WITH INTRAOPERATIVE HT, 25 WERE COMBINED WITH POSTOPERATIVE HT. ON THE OTHER HAND, IN 5 CASES OF POSTOPERATIVE HT, HT AROSE AFTER CAS WITHOUT HISTORY OF INTRAOPERATIVE HT. IN ALL CASES, HT WAS TREATED WITH ETILEFRINE INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247224 PROTEGE RX CAROTID STENT SYSTEM STENT, CAROTID NIM MEDTRONIC COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention