BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK_INTERMEDIATE CATHETER

    MDR report key: 24364998 · Received February 17, 2026

    Report

    Report Number
    3007628272-2026-00010
    Event Type
    Death
    Date Received
    February 17, 2026
    Date of Event
    December 24, 2025
    Report Date
    March 18, 2026
    Manufacturer
    CERENOVUS, INC.
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#: (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: A3A, A5, A6, B2, B4, B5, G3, G6, H2, H3, H6 AND H11. ADDITIONAL INFORMATION WAS RECEIVED ON 20-FEB-2026. SUMMARY: PER THE INFORMATION RECEIVED, THE DATE OF DEATH WAS ON (B)(6), 2025 (7 DAYS AFTER THE PROCEDURE). RELEVANT ANATOMICAL INFORMATION WAS DESCRIBED AS ¿NO CALCIFICATION. TORTUOSITY: ABOUT 90 DEGREE.¿ THE PATIENT WAS A (B)(6) YEAR-OLD MALE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#: (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION B2: DATE OF DEATH: THE DATE OF DEATH WAS NOT REPORTED. SECTION D.2B: PROCODE IS NRY/QJP. SECTION D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. SECTION E1. INITIAL REPORTER PHONE: (B)(6). SECTION H4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED AND THE REPORTED FAILURE COULD NOT BE EVALUATED. THE LOT NUMBER IS NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. CEREBRAL HEMORRHAGE IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE CEREGLIDE57 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. BASED ON THE AVAILABLE INFORMATION, MULTIPLE CLINICAL AND PROCEDURAL FACTORS MAY CONTRIBUTE TO THE EVOLUTION OF A FAINT POSTOPERATIVE HEMORRHAGE INTO A SEVERE OR FATAL INTRACRANIAL BLEED, INCLUDING THE NATURAL PROGRESSION OF ISCHEMIC INJURY, HEMORRHAGIC CONVERSION, ENDOTHELIAL FRAGILITY SECONDARY TO MULTIPLE DEVICE PASSES, PATIENT COMORBIDITIES, AND CEREBRAL EDEMA. THE RELATIONSHIP BETWEEN THE DEVICE USE AND THE REPORTED OUTCOME CANNOT BE EXCLUDED. BASED ON THIS INFORMATION, THIS EVENT DOES MEET US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿DEATH,¿ WITH AN AWARENESS DATE OF 26-JAN-2026. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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

    MANUFACTURER REF# (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B4, B5, G3, G6, H2, AND H11. SECTION B5: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE LOT NUMBER FOR THE EMBOTRAP III 5 MM X 22 MM IS 24J165AV. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 5 MM X 22 MM (ET309522/ LOT#: UNKNOWN), A GEOMETRIC CLOT EXTRACTOR 4.5 X (GCE4528/ 25J188AV), AND A CEREGLIDE57 INTERMEDIATE CATHETER (PRODUCT CODE/ LOT#: UNKNOWN) WERE USED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, A TOTAL OF FIVE PASSES WERE PERFORMED BUT RECANALIZATION WAS NOT ACHIEVED, AND THE PROCEDURE WAS CANCELLED WITH TICI 0 (COMPLETE OCCLUSION). POSTOPERATIVE CT SHOWED A FAINT HEMORRHAGE, AND THE PATIENT WAS KEPT FOR INPATIENT OBSERVATION. APPROXIMATELY SEVEN DAYS AFTER THE PROCEDURE THE HEMORRHAGE EXPANDED; NEUROSURGERY PHYSICIAN PERFORMED EXTERNAL DECOMPRESSION THERAPY. THE PATIENT ULTIMATELY PASSED AWAY DUE TO SYMPTOMATIC INTRACRANIAL HEMORRHAGE. THE PHYSICIAN JUDGED THAT THERE WAS A CAUSAL RELATIONSHIP BETWEEN THE PATIENT¿S OUTCOME AND THE DEVICES USED. THE PHYSICIAN FURTHER COMMENTED THAT ¿ALTHOUGH THE POSTOPERATIVE BLEEDING WAS MINOR, THIS IS A RARE CASE THAT WORSENED AFTER SURGERY. THE REASON FOR THE DETERIORATION IS UNKNOWN. EMBOTRAP AND NIMBUS WERE EACH USED, BUT THERE WAS NO VESSEL STRAIGHTENING OR RESISTANCE DURING TRACTION. IT IS POSSIBLE THAT PERFORMING FIVE PASSES WITH STENT RETRIEVER IN PERIPHERAL VESSELS CAUSED THE BLEEDING. BECAUSE BLEEDING MAY BE UNAVOIDABLE AFTER FIVE PASSES WITH ANY STENT RETRIEVER, THIS WAS NOT CONSIDERED AN EVENT SPECIFIC TO EMBOTRAP OR NIMBUS.¿ CONTINUOUS FLUSH WAS DONE. THE LESION WAS MIDDLE CEREBRAL ARTERY M1-M2. OTHER CONCOMITANT DEVICE WAS TRAK MICROCATHETER. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF MIDDLE CEREBRAL ARTERY M1-M2 IN TREATING ACUTE CEREBRAL INFARCTION. THE DEVICES WERE USED ACCORDING TO IFU. THE PROCEDURE WAS PERFORMED ON (B)(6) 2025. USING J&J PRODUCTS, A TOTAL OF FIVE PASSES WERE PERFORMED (1ST PASS: EMBOTRAP5×22 & CEREGLIDE57. 2ND PASS: NIMBUS & CEREGLIDE57. 3RD PASS: EMBOTRAP5×22 & CEREGLIDE57. 4TH PASS: NIMBUS & CEREGLIDE57. 5TH PASS: EMBOTRAP5×22 & CEREGLIDE57), BUT RECANALIZATION WAS NOT ACHIEVED AND THE PROCEDURE WAS CANCELLED WITH TICI 0. POSTOPERATIVE CT SHOWED A FAINT HEMORRHAGE, BUT BECAUSE THE PATIENT¿S PARESIS IMPROVED, THE PATIENT WAS KEPT FOR INPATIENT OBSERVATION. APPROXIMATELY SEVEN DAYS AFTER THE PROCEDURE THE HEMORRHAGE EXPANDED; NEUROSURGERY PHYSICIAN PERFORMED EXTERNAL DECOMPRESSION THERAPY, BUT UNFORTUNATELY THE PATIENT PASSED AWAY BECAUSE OF SYMPTOMATIC INTRACRANIAL HEMORRHAGE. PHYSICIAN¿S ASSESSMENT OF HEALTH DAMAGE: SERIOUS. REASON FOR SEVERITY DETERMINATION: ALTHOUGH THE POSTOPERATIVE BLEEDING WAS MINOR, THIS IS A RARE CASE THAT WORSENED AFTER SURGERY. THE REASON FOR THE DETERIORATION IS UNKNOWN. PHYSICIAN¿S JUDGMENT ON ASSOCIATION BETWEEN THE HEALTH DAMAGE AND THE PRODUCT (CAUSAL RELATIONSHIP WITH THE PRODUCT): YES. PHYSICIAN¿S COMMENT: EMBOTRAP AND NIMBUS WERE EACH USED, BUT THERE WAS NO VESSEL STRAIGHTENING OR RESISTANCE DURING TRACTION. IT IS POSSIBLE THAT PERFORMING FIVE PASSES WITH STENT RETRIEVER IN PERIPHERAL VESSELS CAUSED THE BLEEDING. BECAUSE BLEEDING MAY BE UNAVOIDABLE AFTER FIVE PASSES WITH ANY STENT RETRIEVER, THIS WAS NOT CONSIDERED AN EVENT SPECIFIC TO EMBOTRAP OR NIMBUS. THE PATIENT PASSED AWAY. CONTINUOUS FLUSH WAS DONE. THE LESION WAS MIDDLE CEREBRAL ARTERY M1-M2. OTHER CONCOMITANT DEVICE WAS TRAK MICROCATHETER.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149502 UNK_INTERMEDIATE CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE NRY CERENOVUS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Male Death TREVO TRAK® MICROCATHETER (STRYKER)