BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEREGLIDE

    MDR report key: 20534790 · Received October 25, 2024

    Report

    Report Number
    3007628272-2024-00052
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    July 30, 2024
    Report Date
    October 29, 2024
    Manufacturer
    CERENOVUS, INC.
    Product Code
    NRY
    UDI-DI
    10886704085409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CORRECTION. "RECOGNIZED DEVICE OR PROCEDURAL COMPLICATIONS (F15) HAS BEEN ADDED AS A HEALTH EFFECT -IMPACT CODE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION A1. PATIENT IDENTIFIER: (B)(6). SECTION D2B: PROCODE IS NRY/QJP. THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31310411 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. PER THE ADDITIONAL INFORMATION RECEIVED ON 23-OCT-2024, REGARDING THE EVENT OF ¿PARENCHYMAL HEMORRHAGE¿; CEREBRAL HEMORRHAGE IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE CEREGLIDE71 INTERMEDIATE CATHETER AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THERE WAS NO ALLEGED QUALITY ISSUES RELATED TO THE USED DEVICE, AS THE DEVICE PERFORMED AS INTENDED. THERE ARE CLINICAL, PHARMACOLOGICAL, AND PROCEDURAL FACTORS, INCLUDING ANEURYSM/VESSEL CHARACTERISTICS, DEVICE SELECTION, DEVICE INTERACTION, AND OPERATOR TECHNIQUE, THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. THE PI ASSESSED THIS EVENT AS UNRELATED TO THE CEREGLIDE71, BUT POSSIBLY RELATED TO THE PRIMARY SURGICAL PROCEDURE; HOWEVER, SINCE THE CEREGLIDE71 DEVICE WAS USED DURING THE PROCEDURE, THE CORRELATING RELATIONSHIP BETWEEN THE EVENT TO THE USED DEVICE AS A CONTRIBUTING FACTOR CANNOT BE RULED OUT ENTIRELY. ADDITIONALLY, THE SEVERITY OF THE EVENT IS UNKNOWN. BASED ON THIS INFORMATION, THIS EVENT DOES MEET US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY,¿ WITH AN AWARENESS DATE OF 23-OCT-2024. 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. 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:(B)(6), A 55-YEAR-OLD MALE PATIENT (SUBJECT (B)(6) ) WITH A MEDICAL HISTORY OF CURRENT DRUG ABUSE (COCAINE, AMPHETAMINE), HYPERLIPIDEMIA, AND ACTIVE SMOKING, PRESENTED WITH AN UNWITNESSED NON-WAKE UP STROKE. LAST TIME SEEN WELL WAS ON (B)(6) 2024, TIME UNKNOWN. SYMPTOMS WERE FIRST OBSERVED ON (B)(6) 2024, TIME UNKNOWN. THE PATIENT WAS THEN PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2024 AT 17:27. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿CARDIOEMBOLIC.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 19 AND A MRS SCORE OF ¿0-NO SYMPTOMS.¿ ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING A CEREGLIDE71 IC 71, 132 CM, US (NIC71115U/ 31310411) FOR AN OCCLUSION AT THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA). THE PRE-PASS MTICI SCORE WAS 1. THE 1ST PASS RESULTED IN A MTICI SCORE OF 2C, WITH CLOT RETRIEVAL IN THE ASPIRATE. NO FURTHER PASSES WERE MADE. DURING THE PROCEDURE, A GUIDEWIRE WAS USED, BUT THE BRAND WAS NOT SPECIFIED. IN ADDITION, A 0.021 TREVO MICROCATHETER AND AN UNKNOWN EMBOGUARD BALLOON GUIDE (PRODUCT CODE/LOT # UNKNOWN) WERE ALSO USED. THERE WERE NO INTRAOPERATIVE STUDY DEVICE DEFICIENCIES. THE PATIENT¿S 24-HOUR POST-PROCEDURE NIHSS SCORE WAS 4. ON (B)(6) 2024, THE PATIENT WAS DISCHARGED HOME FOR SELF-CARE WITH A NIHSS SCORE OF 1 AND A MRS SCORE OF ¿1-NO SIGNIFICANT DISABILITY. ABLE TO CARRY OUT ALL USUAL DUTIES AND ACTIVITIES.¿ ON (B)(6) 2024, THE PATIENT EXPERIENCED THE EVENT OF ¿PARENCHYMAL HEMORRHAGE,¿ WHICH BECAME KNOWN TO THE SITE ON THE SAME DAY AND TO THE SPONSOR ON 23-OCT-2024. THE EVENT WAS ASSESSED BY THE PI AS NOT SERIOUS, MILD IN SEVERITY, AND AS UNRELATED TO THE EMBOTRAP STUDY DEVICE (NOT USED), UNRELATED TO THE EMBOVAC LARGE BORE CATHETER (NOT USED), UNRELATED TO THE CEREGLIDE71, BUT POSSIBLY RELATED TO THE PRIMARY SURGICAL PROCEDURE. THE EVENT WAS NOT MEDICALLY TREATED. THE OUTCOME IS RECORDED AS ¿NOT RECOVERED/NOT RESOLVED,¿ WITH NO END DATE LISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818884 CEREGLIDE CATHETER, THROMBUS RETRIEVER CATHETER, PERCUTANEOUS, NEUROVASCULATURE NRY CERENOVUS, INC. 31310411 10886704085409

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Life Threatening| R