BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOTRAP III 5 MM X 37 MM

    MDR report key: 18229213 · Received November 29, 2023

    Report

    Report Number
    3011370111-2023-00189
    Event Type
    Injury
    Date Received
    November 29, 2023
    Date of Event
    August 2, 2023
    Report Date
    February 28, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT: 23A183AV PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. US FDA DETERMINATION: THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT OF ¿CANCER WITH EXTENSIVE METS WITH TENUOUS CARDIOVASCULAR STATE¿ NOR THE OUTCOME OF ¿DEATH¿ WAS RELATED TO THE EMBOTRAP STUDY DEVICE NOR THE PRIMARY STUDY PROCEDURE. THERE WERE NO ALLEGED QUALITY ISSUES/ MALFUNCTIONS RELATED TO THE DEVICE, AS THE DEVICE PERFORMED AS INTENDED AND NO NEW PATIENT CONSEQUENCES HAVE OCCURRED RELATED TO THE USE OF DEVICE. THE PRINCIPAL INVESTIGATOR ASSESSED THE EVENT OF ¿CANCER WITH EXTENSIVE METS WITH TENUOUS CARDIOVASCULAR STATE¿, WHICH RESULTED IN DEATH, AS UNRELATED TO THE STUDY DEVICE, UNRELATED TO THE ¿LARGE BORE CATHETER/EMBOVAC ASPIRATION CATHETER¿, AND UNRELATED TO THE ¿PRIMARY STUDY PROCEDURE¿. DESPITE THE LIMITED INFORMATION AVAILABLE, THE EVENT DESCRIPTION PROVIDES THAT THE PATIENT SUFFERED FROM METASTATIC CANCER AND WAS IN A VERY WEAK CARDIOVASCULAR STATE. BASED ON THE EVALUATION OF THE INVESTIGATOR AND THE LACK OF EVIDENCE LINKING REPORTED EVENT OF ¿CANCER WITH EXTENSIVE METS WITH TENUOUS CARDIOVASCULAR STATE¿ AND THE OUTCOME OF ¿DEATH¿ TO THE STUDY DEVICE OR STUDY PROCEDURE, THIS EVENT DOES NOT MEET US FDA REPORTING CRITERIA UNDER 21 CFR 803. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. PER THE ADDITIONAL INFORMATION RECEIVED ON 09-NOV-2023, THE PATIENT EXPERIENCED THE EVENT OF A ¿SMALL SUBARACHNOID HEMORRHAGE RELATED TO CATHETER ANGIOGRAPHY.¿ SUBARACHNOID HEMORRHAGE IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF BOTH THE EMBOTRAP III AND EMBOVAC DEVICES AND IS MENTIONED IN THE INSTRUCTIONS FOR USE (IFU) AS HEMORRHAGE. THERE WERE NO ALLEGED QUALITY ISSUES RELATED TO THE USED DEVICES, AS THE DEVICES PERFORMED AS INTENDED. THE PROCEDURE WAS DONE TO TREAT TWO OCCLUSIONS IN TWO DIFFERENT VESSELS, AND THE EMBOTRAP III IS DESIGNED TO WITHSTAND UP TO THREE ATTEMPTS IN ANY ONE VESSEL. THE DEVICE WAS USED FOR A TOTAL OF FOUR PASSES; TWO PASSES FOR THE OCCLUSION AT THE RIGHT CAROTID T, WHICH RESULTED IN A MTICI SCORE OF 2B, AND TWO ADDITIONAL PASSES FOR THE OCCLUSION AT THE RIGHT MCA WHICH RESULTED IN A MTICI SCORE OF 2B. THEREFORE, THE EMBOTRAP III DEVICE WAS NOT USED ACCORDINGLY TO THE INSTRUCTIONS FOR USE (IFU). PROCEDURAL AND CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. PER THE PRINCIPAL INVESTIGATOR¿S ASSESSMENT, THE ADVERSE EVENT WAS ASSESSED AS HAVING A PROBABLE RELATIONSHIP TO THE EMBOTRAP III DEVICE, A PROBABLE RELATIONSHIP TO THE EMBOVAC LARGE BORE CATHETER, AND A POSSIBLE RELATIONSHIP TO THE PRIMARY PROCEDURE. ALTHOUGH THE EVENT WAS ASSESSED AS NOT SERIOUS, THE EVENT REQUIRED A MEDICAL INTERVENTION/TREATMENT TO PRECLUDE PATIENT HARM. ADDITIONALLY, THE PATIENT¿S ULTIMATE OUTCOME ON (B)(6) 2023 WAS DEATH, JUST THREE DAYS AFTER THE EVENT OCCURRED. DESPITE THE PATIENT¿S ADVANCED CANCER STAGE, THE CORRELATION BETWEEN THE OUTCOME OF DEATH AND THE EVENT OF A SUBARACHNOID HEMORRHAGE (WHICH WAS ATTRIBUTED TO THE USE OF THE DEVICES) CANNOT BE RULED OUT COMPLETELY. BASED ON THIS INFORMATION, THE EVENT OF A SUBARACHNOID HEMORRHAGE DOES MEET US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿DEATH¿, WITH AN AWARENESS DATE OF 09-NOV-2023. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2023-00874.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). SECTION B5: MODIFIED INFORMATION WAS RECEIVED ON 23-FEB-2024. SUMMARY: REGARDING THE ADVERSE EVENT OF ¿SMALL SUBARACHNOID HEMORRHAGE RELATED TO CATHETER ANGIOGRAPHY,¿ THE ANSWER FIELD FOR ¿IF EVENT IS BOTH SERIOUS AND DEVICE OR PROCEDURE RELATED, IN THE OPINION OF THE INVESTIGATOR AND IN ACCORDANCE WITH THE LIST OF EXPECTED EVENTS IN THE PROTOCOL AND INSTRUCTIONS FOR USE, IS THE ADVERSE EVENT:¿ WAS UPDATED FROM "BLANK" TO "N/A (DOES NOT MEET ABOVE CRITERIA)." THIS MODIFIED INFORMATION HAS BEEN REVIEWED. 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

    THE PATIENT WAS A 74-YEAR-OLD FEMALE (SUBJECT: (B)(6) WITH A MEDICAL HISTORY OF HYPERTENSION, PRESENTED WITH AN UNWITNESSED WAKE-UP STROKE. LAST TIME SEEN WELL WAS ON (B)(6) 2023 AT 11:00. SYMPTOMS WERE FIRST OBSERVED ON (B)(6) 2023 AT 14:00. THE PATIENT WAS PRESENTED TO THE TREATING HOSPITAL ON THE SAME DAY AT 14:35, 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 29. THE MODIFIED RANKIN SCALE ASSESSMENT SCORE WAS ¿3-MODERATE DISABILITY. REQUIRES SOME HELP, BUT ABLE TO WALK WITHOUT ASSISTANCE.¿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¿PERSISTENT CLOT¿, A 6TH PASS WAS DONE USING A TREVO 4 MM X 41 MM FOR THE MCA OCCLUSION, RESULTING 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. IN ADDITION, A 0.021 TREVO MICROCATHETER, A 0.055 SOFIA AND A 0.060 AXS CATALYST INTERMEDIATE CATHETERS, AN EMBOVAC/CERENOVUS LARGE BORE CATHETER (IC71132UG/30908801), AND A WALRUS BALLOON GUIDE CATHETER WERE ALSO USED. THERE WERE NO REPORTED INTRAOPERATIVE STUDY DEVICE DEFICIENCIES. THE PATIENT¿S 24-HOUR POST-PROCEDURE NIHSS SCORE WAS 12. ON (B)(6) 2023, THE PATIENT EXPERIENCED THE EVENT OF ¿SMALL SUBARACHNOID HEMORRHAGE RELATED TO CATHETER ANGIOGRAPHY¿ WHICH WAS MADE KNOWN TO THE SITE ON 25-OCT-2023. THE PI ASSESSED THIS EVENT AS NOT SERIOUS BUT COULD LEAD TO SERIOUS DETERIORATION OF HEALTH, MILD IN SEVERITY, AND AS HAVING A PROBABLE RELATIONSHIP TO THE EMBOTRAP III DEVICE, A PROBABLE RELATIONSHIP TO THE EMBOVAC LARGE BORE CATHETER, AND A POSSIBLE RELATIONSHIP TO THE PRIMARY PROCEDURE. THE EVENT REQUIRED A MEDICAL TREATMENT/INTERVENTION, ALTHOUGH DETAILS OF THIS WERE NOT MADE AVAILABLE. IT WAS ALSO COMMENTED, ¿OTHER INTERVENTION: CLINICALLY NON-SIGNIFICANT.¿ THE OUTCOME IS RECORDED AS ¿NOT RECOVERED/NOT RESOLVED.¿ IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT EXPERIENCED THE EVENT OF ¿CANCER WITH EXTENSIVE METS WITH TENUOUS CARDIOVASCULAR STATE¿ WHICH BECAME KNOWN THE SITE ON 08-AUG-2023. THE PRINCIPAL INVESTIGATOR (PI) ASSESSED THIS EVENT AS A SERIOUS AND SEVERE ADVERSE EVENT, THAT WAS UNRELATED TO THE ¿EMBOTRAP¿ STUDY DEVICE, UNRELATED TO THE ¿LARGE BORE CATHETER/EMBOVAC ASPIRATION CATHETER¿, AND UNRELATED TO THE ¿PRIMARY STUDY PROCEDURE¿. THE PATIENT WAS NOT MEDICALLY TREATED. THE EVENT WAS FATAL, AS THE PATIENT EXPIRED ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT WAS DISCONTINUED FROM THE STUDY DUE TO DEATH CAUSED BY ¿CANCER PROGRESSION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60075 EMBOTRAP III 5 MM X 37 MM EMBOTRAP III REVASCULARIZATION DEVICE NRY NEURAVI LTD. 23A183AV 10886704084570

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Life Threatening| R 0.021 TREVO MICROCATHETER.| 0.055 SOFIA CATHETER.| 0.060 AXS CATALYST INTERMEDIATE CATHETER.| 132CM LARGE BORE 71 CATHETER.| WALRUS BALLOON GUIDE CATHETER.