BEUDAMED
    FDA Adverse Event Injury Summary report: N

    132CM CEREGLIDE 71 CATHETER

    MDR report key: 19115150 · Received April 16, 2024

    Report

    Report Number
    3007628272-2024-00022
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    March 23, 2024
    Report Date
    May 16, 2024
    Manufacturer
    CERENOVUS, INC.
    Product Code
    QJP
    UDI-DI
    10886704085409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). SECTION B5: ADDITIONAL INFORMATION WAS RECEIVED ON 13-MAY-2024. SUMMARY: PER THE INFORMATION PROVIDED, THE HEMORRHAGE OCCURRED DURING THE PROCEDURE, DURING WHICH TIME, THE TREVO STENT RETRIEVER WAS BEING PULLED BACK. REGARDING WHAT THE PHYSICIAN THINKS MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, IT WAS STATES, ¿INCREASED RADIAL FORCE OF THE TREVO ON THE VESSEL DURING PULL BACK.¿ REGARDING IF THERE WAS ANY VESSEL TRAUMA ASSOCIATED WITH THE EVENT, IT WAS SAID, ¿LIKELY WHEN PULLING THE STENT RETRIEVER BACK.¿ THE LOCATION OF THE BLEED IS KNOWN (FURTHER DETAILS WERE NOT DISCLOSED). REGARDING IF THE EVENT RESULTED IN PROLONGED HOSPITALIZATION, IT WAS STATED, ¿NO. HAD PROLONGED STAY DUE TO INSURANCE AND REHAB FACILITY ACCEPTANCE. 4/17/24. NIHSS 8, MRS 3.¿ PER THE ADDITIONAL INFORMATION RECEIVED ON 13-MAY-2024, THE EVENT OF A SUBARACHNOID HEMORRHAGE OCCURRED WHILE THE TREVO STENT RETRIEVER WAS BEING WITHDRAWN FROM THE VESSEL. MAJOR COMPLICATIONS OF THROMBECTOMY PROCEDURES, SUCH AS SUBARACHNOID HEMORRHAGE, ARE NOT SOLELY CAUSED BY DIRECT VESSEL TRAUMA AND CAN ALSO BE CAUSED BY FRICTIONAL FORCES GENERATED BY THE DEVICE WITHIN THE VESSEL. A STENT RETRIEVER GENERATES MAXIMUM FORCE WHEN THE DEVICE IS BEING WITHDRAWN FROM THE VESSEL; DIFFERENT STENT RETRIEVER DEVICES HAVE SHOWN TO GENERATE STATISTICALLY DIFFERENT FRICTIONAL FORCES, BASED ON THE DESIGN OF THE DEVICE. SINCE THIS IS A WELL-KNOWN OCCURRENCE AND THE TREATING PHYSICIAN FELT THE CAUSE OF THE EVENT WAS RELATED TO THE DESIGN OF THE TREVO STENT-RETRIEVER, THE CORRELATING RELATIONSHIP BETWEEN EVENT TO THE CEREGLIDE71 DEVICE AS A CONTRIBUTING CAUSE CAN BE REASONABLY BE RULED OUT. BASED ON THIS INFORMATION, THE EVENT OF ¿SMALL VOLUME SUBARACHNOID HEMORRHAGE¿ NO LONGER MEETS US FDA REPORTING CRITERIA. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). SECTION A1. PATIENT IDENTIFIER: (B)(6). THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31209881 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. SUBARACHNOID 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 WERE NO ALLEGED QUALITY ISSUES RELATED TO THE USED DEVICE, AS THE DEVICE PERFORMED AS INTENDED. THE PI ASSESSED THE EVENT AS POSSIBLY RELATED TO THE CEREGLIDE71 AND POSSIBLY RELATED TO THE PROCEDURE; THEREFORE, THE CORRELATION RELATIONSHIP BETWEEN EVENT TO USED DEVICE CANNOT BE RULED OUT ENTIRELY. ADDITIONALLY, THE SEVERITY OF THE EVENT IS UNKNOWN, AND THE OUTCOME IS RECORDED AS "RECOVERING/RESOLVING¿ WITH NO END DATE LISTED. BASED ON THIS INFORMATION AND THE ASSESSMENT OF THE PI, THIS EVENT DOES MEET US FDA REPORTING CRITERIA UNDER 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 ((B)(6)), A 73-YEAR-OLD FEMALE ((B)(6)) WITH A HISTORY OF HYPERTENSION 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 PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2024 AT 17:09, WHERE CT IMAGING CONFIRMED AN ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS ¿UNDETERMINED ETIOLOGIES.¿ THE PATIENT¿S BASELINE NIHSS SCORE WAS 18 AND MODIFIED RANKIN SCALE SCORE MRS SCORE WAS ¿0-NO SYMPTOMS.¿ ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING A CEREGLIDE71 INTERMEDIATE CATHETER IC 71, 132 CM, US (NIC71132U/31209881) FOR OCCLUSIONS AT THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA) AND AT THE LEFT INTERNAL CAROTID ARTERY (ICA). THE PRE-PASS MTICI SCORE WAS 0. THE 1ST PASS WAS MADE AT THE ICA OCCLUSION SITE USING THE DIRECT CONTACT ASPIRATION DEVICE ALONE, WHICH RESULTED IN A MTICI SCORE OF 0, WITH NO CLOT RETRIEVAL. THE 2ND PASS WAS MADE AT THE M1 OCCLUSION SITE USING A TREVO STENT-RETRIEVER, WHICH RESULTED IN A MTICI SCORE OF 2B, WITH CLOT RETRIEVAL IN THE STENT-RETRIEVER. DURING THE PROCEDURE, A GUIDEWIRE WAS USED, BUT THE BRAND WAS NOT SPECIFIED. A 0.021 TREVO MICROCATHETER AND AN 8 WALRUS BALLOON GUIDE WERE ALSO USED. THERE WERE NO STUDY DEVICE DEFICIENCIES DURING THE PROCEDURE. THE PATIENT¿S 24-HOUR POST-PROCEDURE NIHSS SCORE WAS 20. ON (B)(6) 2024, THE PATIENT EXPERIENCED THE EVENT OF ¿SMALL VOLUME SUBARACHNOID HEMORRHAGE,¿ WHICH WAS MADE KNOWN TO THE SITE AND SPONSOR ON (B)(6) 2024. THE PRINCIPAL INVESTIGATOR (PI) ASSESSED THIS EVENT AS NOT SERIOUS, MILD IN SEVERITY, AND AS UNRELATED TO THE EMBOTRAP III STUDY DEVICE (NOT USED), UNRELATED TO THE LARGE BORE CATHETER (NOT USED), POSSIBLY RELATED TO THE CEREGLIDE71 INTERMEDIATE CATHETER, AND POSSIBLY RELATED TO THE PRIMARY SURGICAL PROCEDURE. THE EVENT WAS NOT MEDICALLY TREATED. THE OUTCOME IS RECORDED AS ¿RECOVERING/RESOLVING¿ WITH NO END DATE LISTED. THE PATIENT¿S SEVEN-DAY POST-OPERATIVE ASSESSMENTS WERE NOT PERFORMED. THE PATIENT¿S DISCHARGE INFORMATION HAS NOT BEEN ENTERED INTO THE CRF AT THE TIME OF THIS REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672421 132CM CEREGLIDE 71 CATHETER CATHETER, ASPIRATION CATHETER QJP CERENOVUS, INC. 31209881 10886704085409

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Life Threatening GUIDEWIRE (UNSPECIFIED BRAND)| TREVO® 21 MICROCATHETER (STRYKER)| WALRUS¿ 8F BALLOON CATHETER (Q¿APEL)