BEUDAMED
    FDA Adverse Event Death Summary report: N

    REACT CATHETER

    MDR report key: 17786606 · Received September 20, 2023

    Report

    Report Number
    2029214-2023-01803
    Event Type
    Death
    Date Received
    September 20, 2023
    Date of Event
    May 18, 2022
    Report Date
    September 20, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    PMA / PMN Number
    K180715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT RELATED TO REGULATORY REPORT: 2029214-2023-01802. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    T. KLAIL, C. KURMANN, J. KAESMACHER, A. MUJANOVIC, E. PIECHOWIAK, T. DOBROCKY, S. PILGRAM-PASTOR, A. SCUTELNIC, M. HELDNER, J. GRALLA, P. MORDASINI; CLINICAL NEURORADIOLOGY; 2023; 33:237¿244; SAFETY AND EFFICACY OF CAROTID ARTERY STENTING WITH THE CGUARD DOUBLE-LAYER STENT IN ACUTE ISCHEMIC STROKE; DOI.ORG/10.1007/S00062-022-01209-3. MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE THAT PATIENTS POTENTIALLY TREATED WITH PHENOM21, REACT 68 AND REACT 71 CATHETERS HAD COMPLICATIONS. THE ARTICLE REPORTS A SINGLE-CENTER EXPERIENCE WITH THE CGUARD STENT IN THE TREATMENT OF ACUTE ISCHEMIC STROKE (AIS) DUE TO SYMPTOMATICINTERNAL CAROTID ARTERY (ICA) STENOSIS OR OCCLUSION WITH OR WITHOUT INTRACRANIAL OCCLUSION. THEY RETROSPECTIVELY ANALYZED ALL PATIENTS WHO RECEIVED A CGUARD STENT IN THE SETTING OF AIS AT THE STUDY INSTITUTION BETWEEN DECEMBER 2018 AND NOVEMBER 2021. OF THE 33 PATIENTS, 25 (76%) WERE MALE, MEAN AGE WAS 73 YEARS AND THE MEDIAN NIHSS SCORE ON ADMISSION WAS 13. THE CGUARD STENT REPRESENTS A NEW GENERATION OF CAROTID DOUBLE-LAYERED STENTS COMPRISED OF AN INNER OPEN-CELL LASER-CUT NITINOL STENT AND AN OUTER CLOSED-CELL POLYETHYLENE TEREPHTHALATE MESH LAYER, THUS REDUCING THE AMOUNT OF THROMBOGENIC MATERIAL IN THE STENT. PROCEDURE: ALL PATIENTS UNDERWENT THE ENDOVASCULAR PROCEDURES UNDER GENERAL ANESTHESIA. AFTER PUNCTURE OF THE COMMON FEMORAL ARTERY, AN 8 OR 9 FRENCH SHEATH WAS INTRODUCED. A RETROGRADE APPROACH WAS CHOSEN FOR ALL PATIENTS WITH TANDEM OCCLUSIONS. AFTER PLACEMENT OF A GUIDING CATHETER A 0.02100 MICROCATHETER (EITHER A PHENOM 21 OR ONE FORM ANOTHER MANUFACTURER) WAS NAVIGATED THROUGH THE STENOSIS OVER A 0.01400 MICROWIRE UNDER PROXIMAL BALLOON OCCLUSION AND FLOW ARREST. ONLY WHEN INTRACRANIAL ACCESS WAS NOT POSSIBLE DUE TO DIFFICULT VESSEL ANATOMY OR HIGH GRADE STENOSIS, WAS BALLOON ANGIOPLASTY OF THE ICA STENOSIS PERFORMED FIRST. ONCE THE MICROCATHETER POSITION DISTALLY TO THE OCCLUSION OR STENOSIS HAD BEEN CONFIRMED BY A CONTRAST INJECTION, AN INTERMEDIATE 5 OR 6 FRENCH CATHETER (REACT 68/71 OR ONE FROM ANOTHER MANUFACTURER) WAS ADVANCED OVER THE MICROCATHETER INTO THE DISTAL ICA. THE INTRACRANIAL THROMBUS WAS PASSED WITH A MICROCATHETER OVER THE MICROWIRE AND MECHANICAL THROMBECTOMY (MT) WAS PERFORMED USING A STENT RETRIEVER DEVICE WITH DISTAL ASPIRATION. SUCCESSFUL RECANALIZATION WAS DEFINED AS A MODIFIED THROMBECTOMY IN CEREBRAL INFARCTION (MTICI) OF 2B OR 3. BEFORE PERFORMING CERVICAL STENTING OR PTA, A FILTER PROTECTION DEVICE WAS PLACED DISTAL TO THE ICA OCCLUSION TO PROTECT AGAINST DISTAL EMBOLIZATION BEFORE DEFLATION OF THE BALLOON-GUIDED CATHETER AND IMPLANTATION OF THE CGUARD STENT AT THE STENOTIC SITE OF THE ICA. THE FINAL DECISION ON WHETHER TO STENT WAS AT THE DISCRETION OF THE TREATING PHYSICIANS. PREDILATATION AND POST-DILATATION WAS PERFORMED USING BALLOON ANGIOPLASTY. DSA WAS PERFORMED AT THE END OF THE STENT IMPLANTATION PROCESS TO CHECK FOR ACUTE IN-STENT THROMBOSIS, DISTAL EMBOLISM OR OTHER COMPLICATIONS. THE UNDERLYING ETIOLOGY OF THE ICA OCCLUSION OR STENOSIS WAS ATHEROSCLEROSIS IN 29 (88%), ICA DISSECTION IN 3 PATIENTS (6%), AND UNC LEAR IN 1 PATIENT (3%). MEDIAN TIME FROM SYMPTOM ONSET TO RECANALIZATION WAS 371MIN. FINAL INTRACRANIAL RECANALIZATION SUCCESS WAS MTICI2B IN 11/28 PATIENTS (39%) AND MTICI3 IN 17/28 PATIENTS (61%). AFTER DEPLOYMENT, 82% OF STENTS WERE DILATED WITH PTA AND GOOD RE CANALIZATION WAS ACHIEVED IN ALL PATIENTS.  COMPLICATIONS: ACUTE IN-STENT THROMBUS FORMATION OCCURRED IN THREE PATIENTS (9%, 3/33). AFTER PTA AND ASPIRATION (N= 1), ASPIRATION ALONE (N= 1) OR NO RESCUE MANEUVER (DUE TO ONLY MINOR AND PERIPHERAL THROMBUS, N= 1), ALL STENTS WERE PATENT AT THE END OF THE INTERVENTION. GLYCOPROTEIN IIB/IIIA INHIBITORS OR HEPARIN WERE NOT ADMINISTERED IN THESE CASES. IATROGENIC ARTERIAL DISSECTION OCCURRED IN FOUR PATIENTS (12%), ONLY ONE DISSECTION OCCURRED AFTER CAS WITH CGUARD, THREE OCCURRED WHILE GAINING INTRACRANIAL ACCESS FOR MECHANICAL THROMBECTOMY BY ADVANCING THE GUIDE/INTERMEDIATE CATHETER THROUGH DUE TO TORTUOUS VESSEL ANATOMY. AFTER STENTING WITH THE CGUARD, THERE WAS A SUSPECTED SMALL DISSECTION IN ONE CASE AT THE DISTAL END OF THE STENT WITHOUT HEMODYNAMIC RELEVANCE, AND FURTHER TREATMENT WAS NOT DEEMED NECESSARY. OF THE OTHER THREE CASES, TWO INVOLVED THE CERVICAL PART OF THE ICA AND WHICH REQUIRED ADDITIONAL STENTING AND EXTENSION OF THE LESION TO THE SUPRAOPHTHALMIC SEGMENT WITHOUT HEMODYNAMIC RELEVANCE OCCURRED IN ONE PATIENT. IN THREE OF THEM, ONLY THE CERVICAL PART OF THE ICA WAS INVOLVED AND EXTENSION OF THE LESION TO THE SUPRAOPHTHALMIC SEGMENT OCCURRED IN ONE PATIENT. TWO DISSECTIONS WERE FLOW-LIMITING AND REQUIRED ADDITIONAL STENTING. DISTAL EMBOLISMS WERE FOUND IN THE INFARCT TERRITORY ON FINAL CONTROL DSA AFTER STENTING IN TWO PATIENTS (6%) AND NEW CLINICALLY ASYMPTOMATIC INFARCTS IN NEW TERRITORY IN FOLLOW-UP IMA GING IN TWO OTHER PATIENTS (6%). 1 PATIENT DIED DUE TO SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH) AND 1 PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL BEFORE FOLLOW-UP EXAMINATION). A SICH OCCURRED IN ONE PATIENT (3%) AND ASYMPTOMATIC INTRACRANIAL HEMORRHAGE (ASICH) IN NINE PATIENTS (27%). OF THE NINE PATIENTS WITH AICH, SEVEN WERE DUE TO HEMORRHAGIC TRANSFORMATION (FIVE PATIENTS WITH HEMORRHAGIC INFARCTION (HI) 1, ONE WITH HI2 AND TWO WITH PARENCHYMAL HEMATOMA (PH) 2) AND TWO DUE TO SAH. MEDIAN DURATION OF FOLLOW-UP AFTER THE PROCEDURE WAS 90 DAYS. POSTINTERVENTIONAL STENT OCCLUSION OCCURRED IN ONE PATIENT AFTER 49 DAYS, 1 PATIENT SUFFERED A TRANSIENT ISCHEMIC ATTACK (3%) AND 12 PATIENTS (36%) HAD A FOLLOW-UP MRS= 2 AT 3 MONTHS. THE MEDIAN NIHSS AT 3 MONTHS IN ALL SURVIVORS WAS 1. THE MORTALITY RATE AT 3 MONTHS WAS 24% (8 PATIENTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585865 REACT CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 REACT-68 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Death