BEUDAMED
    FDA Adverse Event Injury Summary report: N

    132CM CEREGLIDE 71 CATHETER

    MDR report key: 19415699 · Received May 29, 2024

    Report

    Report Number
    3007628272-2024-00030
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    May 19, 2024
    Report Date
    July 2, 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 Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). SECTION A1. PATIENT IDENTIFIER: (B)(6). SECTION D4: THE PRODUCT CATALOG AND LOT NUMBER WAS NOT AVAILABLE / NOT REPORTED. THE UNIQUE IDENTIFIER (UDI) AND EXPIRATION DATE OF THE DEVICE IS NOT KNOWN. SECTION E1 ¿ INITIAL REPORTER: THE CUSTOMER CONTACT INFORMATION, INCLUDING NAME, OCCUPATION, PHONE, FAX, AND E-MAIL ADDRESS, WAS NOT REPORTED. HEMORRHAGE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ENDOVASCULAR MECHANICAL THROMBECTOMY FOR ACUTE ISCHEMIC STROKE CASES AND IS LISTED IN THE CEREGLIDE71 INSTRUCTIONS FOR USE (IFU) AS SUCH. THERE WERE NO ALLEGED QUALITY ISSUES RELATED TO THE USED DEVICE, AS THE DEVICE PERFORMED AS INTENDED. THE EVENT OF ¿ASYMPTOMATIC INTRACRANIAL HEMORRHAGE¿ WAS ASSESSED BY THE PI AS POSSIBLY RELATED TO THE CEREGLIDE71, AND POSSIBLY RELATED TO THE PRIMARY PROCEDURE; THEREFORE, THE CORRELATING RELATIONSHIP BETWEEN EVENT TO THE CEREGLIDE71 AS A CONTRIBUTING FACTOR CANNOT BE RULED OUT ENTIRELY. THE EVENT REQUIRED MEDICINAL TREATMENT AND THE SEVERITY OF THE EVENT IS UNKNOWN, AS THE OUTCOME IS RECORDED AS ¿NOT RECOVERED/NOT RESOLVED.¿ 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). PER THE ADDITIONAL INFORMATION RECEIVED ON 24-JUN-2024, THE EVENT OF ¿ASYMPTOMATIC INTRACRANIAL HEMORRHAGE¿ WAS CLARIFIED AS BEING CLASSIFIED AS A HEMORRHAGIC TRANSFORMATION OF THE INDEX STROKE. A HEMORRHAGIC TRANSFORMATION (HT) REFERS TO A SPECTRUM OF ISCHEMIA-RELATED BRAIN HEMORRHAGE, THAT HAPPENS BECAUSE OF THE DIMINISHED AUTOREGULATION IN VESSELS SUPPLYING THE INFARCTED TISSUES AND THUS INCREASES THE RISK OF HEMORRHAGE UPON RETURN OF NORMAL BLOOD FLOW. THE EVENT IS ATTRIBUTED TO A REPERFUSION INJURY. THEREFORE, THE EVENT OF ¿ASYMPTOMATIC INTRACRANIAL HEMORRHAGE¿ NO LONGER MEETS US FDA REPORTING CRITERIA.

    Description of Event or Problem · 0

    AS REPORTED VIA THE EXCELLENT STUDY (B)(6), A 48-YEAR-OLD MALE (SUBJECT (B)(6)) WITH A MEDICAL HISTORY OF DIABETES AND SMOKING (ACTIVE), PRESENTED WITH AN UNWITNESSED NON-WAKE UP STROKE. LAST TIME SEEN WELL WAS ON (B)(6) 2024 AT 00:00. SYMPTOMS WERE FIRST OBSERVED ON THE SAME DAY, AT 19:30. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON (B)(6) 2024 AT 20:40. 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 21 AND A MRS SCORE OF ¿0-NO SYMPTOMS.¿ ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING AN UNKNOWN DEVICE (PRODUCT CODE/LOT # UNKNOWN). NO INFORMATION REGARDING THIS PROCEDURE WERE MADE AVAILABLE AT THE TIME OF THIS REVIEW. IT IS UNKNOWN IF THERE WERE ANY INTRAOPERATIVE STUDY DEVICE DEFICIENCIES. THE PATIENT¿S 24-HOUR POST-PROCEDURE NIHSS SCORE WAS 13. ON 19-MAY-2024, THE PATIENT EXPERIENCED THE ADVERSE EVENT OF ¿ASYMPTOMATIC INTRACRANIAL HEMORRHAGE,¿ WHICH BECAME KNOWN TO THE SITE ON THE SAME DAY AND TO THE SPONSOR ON 22-MAY-2024. THE PRINCIPAL INVESTIGATOR (PI) ASSESSED THIS EVENT AS NOT SERIOUS, MILD IN SEVERITY, AND AS NOT RELATED TO THE STUDY DEVICE, NOT RELATED TO THE LARGE BORE CATHETER, POSSIBLY RELATED TO THE CEREGLIDE71, AND POSSIBLY RELATED TO THE PRIMARY PROCEDURE. THE EVENT WAS NOT MEDICALLY TREATED. THE OUTCOME IS RECORDED AS ¿NOT RECOVERED/NOT RESOLVED,¿ 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
    1939340 132CM CEREGLIDE 71 CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE NRY CERENOVUS, INC. 31202403 10886704085409

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Life Threatening| R