BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVIVE SE 4.5MM OUS

    MDR report key: 7332082 · Received March 12, 2018

    Report

    Report Number
    3008114965-2018-00560
    Event Type
    Injury
    Date Received
    March 12, 2018
    Date of Event
    October 7, 2016
    Report Date
    February 13, 2018
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    DXE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT(B)(4). ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DIAMETER OF THE TARGET VESSEL WAS 3.97MM AT THE PROXIMAL PORTION AND 2.44MM AT THE DISTAL PORTION. THE LENGTH OF THE OCCLUSION WAS 16MM. IT IS UNKNOWN IF THERE WAS THROMBUS. COMPLAINT CONCLUSION: AS REPORTED VIA THE REVIVE SE PMS JAPAN STUDY (409-08) A REVIVE SE (FRS21452299 / T10108) DID NOT ADEQUATELY REMOVE THE THROMBUS AND THE PATIENT EXPERIENCED POST PROCEDURE ASYMPTOMATIC HEMORRHAGIC INFARCTION, FOLLOWED BY SYMPTOMATIC CEREBRAL INFARCTION 2 DAYS LATER. THE 70-YEAR-OLD MALE WITH NO HISTORY OF CEREBRAL STROKE PRESENTED WITH AN ACUTE STAGE OF CEREBRAL STROKE DUE TO RIGHT INTRACRANIAL INTERNAL CAROTID ARTERY OCCLUSION ON 10/6/2016. PRE-OP ASPECTS-DWI WAS 9 POINTS, NIHSS WAS 6 POINTS AND TICI WAS 0. THE OCCLUDED PORTION WAS MODERATELY TORTUOUS WITH NO STENOSIS IN THE PROXIMAL TO THE OCCLUSION. THE DIAMETER OF THE TARGET VESSEL WAS 3.97MM PROXIMAL TO THE OCCLUSION AND 2.44MM DISTALLY. THE LENGTH OF THE OCCLUSION WAS 16MM. T-PA WAS NOT ADMINISTERED. THE REVIVE SE WAS DELIVERED TO THE LESION AND DEPLOYED FOUR TIMES WITH A TICI RESULT OF 2A. THEN ANOTHER DEVICE (PENUMBRA) WAS DEPLOYED AND OBTAINED TICI RESULT OF 2A. THE POSTOPERATIVE NIHSS WAS 9 POINTS. RIGHT AFTER THE PROCEDURE, THE PATIENT DEVELOPED ASYMPTOMATIC SAH IN THE OCCLUDED VESSEL REGION. THE CEREBRAL INFARCTION BECAME WORSE, AND THE PATIENT DEVELOPED SYMPTOMATIC CEREBRAL INFARCTION APPROXIMATELY 2 DAYS AFTER INITIALLY PRESENTING TO THE HOSPITAL. SYMPTOMS OF THE INFARCTION WERE CONSCIOUSNESS DISORDER, SPEECH DISORDER, SENSORY DISORDER, AND HEMIPLEGIA OF THE LEFT LOWER EXTREMITY. ON (B)(6) 2016 NIHSS WAS 16. ON (B)(6) 2016 ASPECTS-DWI WAS 5 POINTS. ON (B)(6) 2016, MRS WAS 5 POINTS, AND ON (B)(6) 2016 , ASPECTS-CT WAS 3 POINTS. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED EVENT. STROKE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THROMBECTOMY PROCEDURES AND THE REVIVE SE. LITERATURE REVIEW FOUND THAT HEMORRHAGIC TRANSFORMATION, WHICH REFERS TO A SPECTRUM OF ISCHEMIA-RELATED BRAIN HEMORRHAGE, IS A FREQUENT SPONTANEOUS COMPLICATION OF ISCHEMIC STROKE. THE INCIDENCE OF SPONTANEOUS HEMORRHAGIC TRANSFORMATION RANGES FROM 38% TO 71% IN AUTOPSY STUDIES AND FROM 13% TO 43% IN CT STUDIES. STROKE FOLLOWING THROMBECTOMY CAN ALSO BE RELATED TO REPERFUSION SYNDROME. RESTORATION OF VASCULAR SUPPLY TO AN ORGAN TEMPORARILY DEPRIVED OF BLOOD FLOW, WHILE EFFECTIVE IN PROVIDING OXYGENATION, OFTEN PARADOXICALLY RESULTS IN INJURY OF THE AFFECTED TISSUE BED RELATING TO THE ACTIVATION OF IMMUNE AND COAGULATION SYSTEMS. CONTINUED TOTAL OCCLUSION OF AFFECTED ARTERIAL SEGMENT IS ALSO A KNOWN PROCEDURAL EVENT RELATED TO THE REVIVE SE AND THE THROMBECTOMY PROCEDURE. VESSEL CHARACTERISTICS OR THROMBUS COMPOSITION MAY HAVE CONTRIBUTED TO THE EVENT. VESSEL TORTUOSITY AND CALCIFICATION OF THROMBUS CAN RESULT IN DIFFICULTY IN ADVANCING THE DEVICE THROUGH THE THROMBUS. IT SHOULD BE NOTED THAT A COMPETITOR¿S DEVICE ALSO FAILED TO ADEQUATELY REMOVE THE CLOT. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: GUIDING CATHETER (9FR OPTIMO) AND A MICRO CATHETER (MARKSMAN). PHYSICAL MANUFACTURER: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). INFORMATION REGARDING PATIENT AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED VIA (B)(6), RIGHT AFTER THE PROCEDURE, THE (B)(6) MALE PATIENT DEVELOPED ASYMPTOMATIC SUBARACHNOID HEMORRHAGE (SAH) IN THE OCCLUDED VESSEL REGION ((B)(6) 2016). ON (B)(6) 2016, THE CEREBRAL INFARCTION BECAME WORSE AND THE PATIENT DEVELOPED SYMPTOMATIC CEREBRAL INFARCTION. THE SYMPTOMS THAT WERE CAUSED ARE CONSCIOUSNESS DISORDER, SPEECH DISORDER, SENSORY DISORDER, AND HEMIPLEGIA OF THE LEFT LOWER EXTREMITY. ON (B)(6) 2016, THE RESULT OF NIHSS WAS 16 POINTS. ON (B)(6) 2016, THE RESULT OF ASPECTS-DWI WAS 5 POINTS. ON (B)(6) 2016, THE RESULTS OF MRS WAS 5 POINTS. ON (B)(6) 2016, THE RESULT OF ASPECTS-CT WAS 3 POINTS. INITIALLY, THE PATIENT HAD DEVELOPED AN ACUTE STAGE OF CEREBRAL STROKE DUE TO RIGHT INTRACRANIAL INTERNAL CAROTID ARTERY OCCLUSION OF THE INTERNAL CAROTID ARTERY SYSTEM ((B)(6) 2016 AT 12;00PM). ON (B)(6) 2016 AT 9:45AM, THE PATIENT WAS SENT TO THE HOSPITAL. THE PREOPERATIVE RESULTS OF ASPECTS-DWI WAS 9 POINTS, NIHSS WAS 6 POINTS, AND TICI WAS 0 POINT. THE OCCLUDED PORTION WAS MODERATELY TORTUOUS AND NO STENOSIS IN THE PROXIMAL PORTION OF THE OCCLUSION WAS CONFIRMED. THE DIAMETER OF THE TARGET VESSEL WAS 3.97MM AT THE PROXIMAL PORTION AND 2.44MM AT THE DISTAL PORTION. THE LENGTH OF THE OCCLUSION WAS 16MM. THE T-PA WAS NOT APPLICABLE. ON THE SAME DAY (12:25PM), THE PROCEDURE WAS INITIATED BY MAKING PUNCTURE. A GUIDING CATHETER (9FR OPTIMO) WAS INSERTED AT 1:54PM, A MICRO CATHETER (MARKSMAN) WAS INSERTED AT 2:03PM AND A THROMBOSIS REMOVAL DEVICES (SOLITAIRE FR, 5.4MM PENUMBRA) WERE INSERTED. THE COMPLAINT REVIVE SE WAS DELIVERED TO THE LESION AND DEPLOYED FOUR TIMES AND OBTAINED TICI RESULT OF 2A. THEN ANOTHER DEVICE (PENUMBRA) WAS DEPLOYED AND OBTAINED TICI RESULT OF 2A. THE PROCEDURE FINISHED AT 4:18PM. THE POSTOPERATIVE RESULT OF NIHSS WAS 9 POINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173035 REVIVE SE 4.5MM OUS EMBOLECTOMY CATHETER DXE MEDOS INTERNATIONAL SARL T10108

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening