BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOTRAP III 5 MM X 37 MM

    MDR report key: 18356087 · Received December 19, 2023

    Report

    Report Number
    3011370111-2023-00214
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    November 27, 2023
    Report Date
    January 11, 2024
    Manufacturer
    NEURAVI LTD.
    Product Code
    NRY
    UDI-DI
    10886704084570
    PMA / PMN Number
    K193063
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). PER THE ADDITIONAL INFORMATION RECEIVED ON 09-JAN-2024, IT HAS BEEN DISCLOSED THAT THERE WAS NO VESSEL TRAUMA ASSOCIATED WITH THE EVENT. IT WAS FURTHER COMMENTED, ¿THERE IS A TINY AMOUNT OF STAINING IN INSULAR REGION, AS ALSO SEEN BY MRI IMAGING.¿ THIS CONFIRMS THE STAINING REPRESENTS CONTRAST STAINING WITH HEMORRHAGIC TRANSFORMATION (A REPERFUSION INJURY). FURTHER, THE PATIENT RECOVERED THE FOLLOWING DAY WITHOUT MEDICAL INTERVENTION, WITH AN IMPROVED NIHSS SCORE FROM 9 TO 2 (NIHSS SCORE 1-4 EQUATES TO VERY MINOR STROKE SYMPTOMS) AND NO PERMANENT DEFICITS. BASED ON THIS INFORMATION, THE EVENT OF ¿¿EXPECTED LOCATION OF ACUTE RIGHT MCA TERRITORY INFARCTION WITH PETECHIAL HEMORRHAGE¿ DOES NOT MEET THE DEFINITION OF A SERIOUS INJURY AND WAS MOST LIKELY A REPERFUSION INJURY CAUSED BY THE PROCEDURE. THEREFORE, THE EVENT NO LONGER MEETS US FDA REPORTING CRITERIA AND WE ARE UNRE-PORING THE EVENTS.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION A1. PATIENT IDENTIFIER (B)(6). SECTION D3 ¿ THE PRODUCT CATALOG AND LOT NUMBERS WERE NOT REPORTED, UDI UNAVAILABLE. CEREBRAL HEMORRHAGE AND CEREBRAL INFARCTION ARE BOTH KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF THE EMBOTRAP III DEVICE AND ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THERE WERE NO ALLEGED QUALITY ISSUES RELATED TO THE DEVICE USED, AS THE DEVICE PERFORMED AS INTENDED. THE ADVERSE EVENT TERM, ¿EXPECTED LOCATION OF ACUTE RIGHT MCA TERRITORY INFARCTION WITH PETECHIAL HEMORRHAGE,¿ SUGGESTS THAT THE EVENT WAS A HEMORRHAGIC INFARCTION, BASED ON THE LOCATION AND THE PETECHIAL HEMORRHAGING NOTED ON THE DIAGNOSTIC IMAGING USED. A HEMORRHAGIC INFARCT (HI) IS A TYPE OF ISCHEMIC INFARCT THAT OCCURS WHEN THERE IS BLEEDING IN NECROTIC CEREBRAL TISSUE AND WHEN PERIPHERAL BLOOD EXTRAVASATES ACROSS A DISRUPTED BLOOD-BRAIN BARRIER INTO THE BRAIN AFTER AN ISCHEMIC STROKE; THIS IS CLASSIFIED AS A HEMORRHAGIC TRANSFORMATION (HT) SUBTYPE. A HEMORRHAGIC TRANSFORMATION IS NOT CAUSED BY THE DEVICES USED NOR THE PROCEDURE ITSELF BUT IS ATTRIBUTED TO THE REPERFUSION INJURY THAT OCCURS UPON RETURN OF NORMAL BLOOD FLOW. HOWEVER, SINCE THE PI ASSESSED THE EVENT AS POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PRIMARY SURGICAL PROCEDURE, THE CORRELATION BETWEEN USED DEVICE TO THE EVENT CANNOT BE RULED OUT. FURTHER INFORMATION REGARDING THE EVENT AND PROCEDURE DETAILS WILL BE REQUESTED TO PROPERLY ASSESS THE EVENT. BASED ON THE AVAILABLE INFORMATION AND THE ASSESSMENT OF THE PI, THIS EVENT WILL BE CONSERVATIVELY REPORTED TO THE US FDA REPORTING UNDER CRITERIA 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY.¿ THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. 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. 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 COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    AS REPORTED VIA THE EXCELLENT STUDY (CNV_2017_02), A PATIENT OF UNKNOWN AGE, SEX, AND MEDICAL HISTORY (SUBJECT 915-154) PRESENTED WITH AN UNKNOWN STROKE TYPE ON AN UNKNOWN DATE. AT THE TIME OF THIS REVIEW, NO INFORMATION OTHER THAN THE ADVERSE EVENT, HAS BEEN ENTERED INTO THE CLINICAL DATABASE, THE CRF. ON (B)(6) 2023, THE PATIENT EXPERIENCED THE ADVERSE EVENT OF ¿EXPECTED LOCATION OF ACUTE RIGHT MCA TERRITORY INFARCTION WITH PETECHIAL HEMORRHAGE,¿ WHICH BECAME KNOWN TO THE SITE AND SPONSOR ON (B)(6) 2023. THE PRINCIPAL INVESTIGATOR (PI) ASSESSED THE EVENT AS NOT SERIOUS, MILD IN SEVERITY, AND AS POSSIBLY RELATED TO THE STUDY DEVICE, NOT RELATED TO THE LARGE BORE CATHETER, AND POSSIBLY RELATED TO THE PRIMARY SURGICAL PROCEDURE. THIS EVENT WAS NOT MEDICALLY TREATED, AND THE OUTCOME IS RECORDED AS ¿RECOVERING/RESOLVING,¿ WITH NO END DATE LISTED. NO FURTHER INFORMATION WAS MADE AVAILABLE AT THE TIME OF THIS REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138901 EMBOTRAP III 5 MM X 37 MM CATHETER, THROMBUS RETRIEVER NRY NEURAVI LTD. 23H148AV 10886704084570

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening